MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1608062

Device Problems Loss of or Failure to Bond (1068); Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 08/31/2023

Event Type  malfunction  

Event Description

It was reported that during a port placement procedure, the hemostatic valve allegedly came out of the sheath.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 return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 11/2024) 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 : device pending return.

Manufacturer Narrative

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 8.0fr peel-apart sheath and vessel dilator was returned for evaluation.Gross visual and microscopic visual evaluations were performed.Bends and twists were noted throughout the fully peeled 8.0fr peel-apart sheath shafts.What appeared to be the valve caps with the valve, was still loaded on the vessel dilator hub.An attempt to remove the valve caps from the vessel dilator was performed and was successful.The valve caps were split into two.Material transfer was found on both the valve caps and the t-handle bond areas.The distal tip of the vessel dilator was noted to be fractured.Manufacturing site evaluation of the sample found that the sheath is completely peeled and the valve top caps and valve were not present on the t-handle halves as normal and a closer view revelated a fracture in the tip of the dilator apparently caused during the insertion process into the patient.Therefore the investigation is confirmed for the reported loss or failure to bond and material separation issues.Therefore, the cause of these conditions is related to manufacturing.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (expiration date: 11/2024).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 during a port placement procedure, the hemostatic valve allegedly came out of the sheath.There was no reported patient injury.

Event Description

It was reported that during a port placement procedure, the hemostatic valve allegedly came out of the sheath when the dilator was pulled out.The procedure was completed without no complications.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.Investigation summary: one fully peeled 8.0fr peel-apart sheath and vessel dilator was returned for evaluation.Gross visual and microscopic visual evaluations were performed.Bends and twists were noted throughout the fully peeled 8.0fr peel-apart sheath shafts.What appeared to be the valve caps with the valve, was still loaded on the vessel dilator hub.An attempt to remove the valve caps from the vessel dilator was performed and was successful.The valve caps were split into two.Material transfer was found on both the valve caps and the t-handle bond areas.Manufacturing site evaluation of the sample found that the sheath is completely peeled and the valve top caps and valve were not present on the t-handle halves as normal and a closer view revelated a fracture in the tip of the dilator apparently caused during the insertion process into the patient.Therefore the investigation is confirmed for the reported loss or failure to bond and material separation issues.Therefore, the cause of these conditions is related to manufacturing.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiration date: 11/2024), g3.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.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
• 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: 17819575
• MDR Text Key: 324288601
• Report Number: 3006260740-2023-04304
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026430
• UDI-Public: (01)00801741026430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

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: 1608062
• Device Lot Number: REHS2028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2023
• 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