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

Catalog Number 1716000J

Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Material Separation (1562); Separation Failure (2547); Material Integrity Problem (2978)

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

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number has not been cleared in the us, but is similar to the powerport slim implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510k number for the powerport slim implantable port, chronoflex single-lumen, kit, 6f products is identified.As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.

Event Description

It was reported that during a port placement procedure, the valve of the sheath allegedly damaged upon peeling.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport slim implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510k number for the powerport slim implantable port, chronoflex single-lumen, kit, 6f products is identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one fully peeled 6.5f introducer peel-apart sheath and one vessel dilator was returned for evaluation.Gross visual evaluation was performed.Bunching and material deformation was noted throughout both peel-apart sheaths.The investigation is confirmed for the reported sheath broken and identified separation failure issue as the valve was noted to be detached from the t-handle.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.H10: g3, h6 (device) h11: h6 (method, result, conclusion) 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 during a port placement procedure, the valve of the sheath allegedly damaged upon peeling.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport slim implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510k number for the powerport slim implantable port, chronoflex single-lumen, kit, 6f products is identified in d2 and g4.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: d4 (expiry date: 06/2023).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 during a port placement procedure, the valve of the sheath allegedly damaged upon peeling.There was no reported patient injury.

Event Description

It was reported that during a port placement procedure, the valve of the sheath allegedly damaged upon peeling.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport slim implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510k number for the powerport slim implantable port, chronoflex single-lumen, kit, 6f products is identified in d2 and g4.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 fully peeled 6.5f introducer peel-apart sheath and one vessel dilator was returned for evaluation.Gross visual evaluation was performed.Bunching and material deformation was noted throughout both peel-apart sheaths.Manufacturing site evaluation of the sample found that the top cap was detached from one side of the handle, where the fr of the sleeve is indicated, it was observed that after the top cap was detached, the valve was not present in the sample, traces of ultrasonic welding were observed in the middle of the detached top cap in the section that joins the handle.Therefore the investigation is confirmed for the identified material separation and loss or failure to bond issue as the valve was noted to be detached from the t-handle.However the investigation is inconclusive for the reported material integrity problem as there was no objective evidence obtained during investigation.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.H10: (expiry date: 06/2023).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.

• Brand Name: POWERPORT SLIM 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: 16191504
• MDR Text Key: 307571534
• Report Number: 3006260740-2022-06078
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111631
• UDI-Public: (01)00801741111631
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072549
• 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
• Report Date: 08/30/2023

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 Catalogue Number: 1716000J
• Device Lot Number: REGQ2806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 03/14/2023; 03/29/2023; 08/29/2023
• Supplement Dates FDA Received: 03/26/2023; 04/21/2023; 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• 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