MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1606052

Device Problems Suction Problem (2170); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that some time post port placement, the port system was allegedly occluded.It was further reported that there was no problem with the catheter and only the port body was removed.The procedure was completed by replacing another port body.There was no reported patient injury.

Event Description

It was reported that some time post port placement, the port system was allegedly occluded.It was further reported that the device allegedly had a suction issue.Reportedly, the port body was removed and replaced.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport clearvue implantable port was returned for evaluation.Functional, gross visual, microscopic visual evaluations and destructive testing were performed.An in-house syringe was attached to a safety infusion set and the non-coring needle was inserted into the port septum.Infusion and aspiration were attempted but was unsuccessful.The investigation is inconclusive for the reported port body occlusion and suction issues as the exact circumstances at the time of the reported event was unknown and cannot be verified from the provided samples.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport clearvue implantable port was returned for evaluation.Functional, gross visual, microscopic visual evaluations and destructive testing were performed.A small solid silicone material segment was found inside the port body, infusion and aspiration were attempted but was unsuccessful.Manufacturing site evaluation of the sample found that the septum of the port had several perforations which indicated that the device had been placed for a long time inside the patient and inside it was not observed any material that could cause the occlusion of the port.Inspection of the sample finding inside the port chamber showed a material that appeared to be silicone and that was occluding a section of the port stem and the material appears to be silicone.The investigation is inconclusive for the reported port body occlusion and suction issues as the exact circumstances at the time of the reported event was unknown.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that some time post port placement, the port system was allegedly occluded.It was further reported that the device allegedly had a suction issue.Reportedly, the port body was removed and replaced.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport clearvue implantable port was returned for evaluation.Functional, gross visual, microscopic visual evaluations and destructive testing were performed.A small solid silicone material segment was found inside the port body, infusion and aspiration were attempted but was unsuccessful.Manufacturing site evaluation of the sample found that the septum of the port had several perforations which indicated that the device had been placed for a long time inside the patient and inside it was not observed any material that could cause the occlusion of the port.Inspection of the sample finding inside the port chamber showed a material that appeared to be silicone and that was occluding a section of the port stem and the material appears to be silicone.Therefore, the investigation is confirmed for the reported occlusion and suction issue as the silicone was introduced into the stem preventing proper flow in the port.The root cause was determined to be manufacturing related.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: g3 h11: h6 (result, conclusion) h11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.

Event Description

It was reported that some time post port placement, the port system was allegedly occluded.It was further reported that the device allegedly had a suction issue.Reportedly, the port body was removed and replaced.There was no reported patient injury.

Event Description

It was reported that three days post a port placement, the port system was allegedly occluded.It was further reported that the device allegedly had a suction issue.Reportedly, the port body was removed and replaced.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: (expiry date: 08/2023).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that three days post a port placement, the port system was allegedly occluded.It was further reported that the device allegedly had a suction issue.Reportedly, the port body was removed and replaced.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport clearvue implantable port was returned for evaluation.Functional, gross visual, microscopic visual evaluations and destructive testing were performed.A small solid silicone material segment was found inside the port body, infusion and aspiration were attempted but was unsuccessful.Manufacturing site evaluation of the sample found that the septum of the port had several perforations which indicated that the device had been placed for a long time inside the patient and inside it was not observed any material that could cause the occlusion of the port.Inspection of the sample finding inside the port chamber showed a material that appeared to be silicone and that was occluding a section of the port stem and the material appears to be silicone.Therefore, the investigation is confirmed for the reported occlusion and suction issue as the silicone was introduced into the stem preventing proper flow in the port.The root cause was determined to be manufacturing related.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 08/2023), g3, h2, h6 (method) h11: h6 (result, conclusion) h11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16065742
• MDR Text Key: 307817380
• Report Number: 3006260740-2022-05887
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026409
• UDI-Public: (01)00801741026409
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1606052
• Device Catalogue Number: 1606052
• Device Lot Number: REGQ2873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 03/24/2023; 07/19/2023; 09/12/2023; 11/15/2023; 01/24/2024
• Supplement Dates FDA Received: 03/29/2023; 07/20/2023; 09/14/2023; 12/14/2023; 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1