MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 APHERESIS PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number A710962

Device Problems Fluid/Blood Leak (1250); Expulsion (2933)

Patient Problems Bruise/Contusion (1754); Unspecified Infection (1930); Skin Erosion (2075)

Event Date 02/28/2023

Event Type  Injury  

Manufacturer Narrative

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.(expiry date: 11/2022).

Event Description

It was reported that approximately ten months post port placement procedure, tissue above the port had allegedly broken down.It was further reported that the port had allegedly eroded to the point it was exposed.Reportedly patient had developed infection and bruising in the tissue above the port.The port was removed.The current status of the patient was unknown.

Event Description

It was reported that approximately ten months post port placement procedure, tissue above the port had allegedly broken down.It was further reported that the port had allegedly eroded to the point it was exposed and the device allegedly leaked.Reportedly patient had developed infection and bruising in the tissue above the port.The port was removed.The current status of the patient was unknown.

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 powerflow implantable port attached to a catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.A complete diagonal break was noted at the distal end of the catheter attached and the edges of the complete diagonal break were noted to be uneven with the surface noted to be glossy with striations and residue throughout the surface.Upon infusion, a leak was also observed from the funnel.Therefore the investigation is confirmed for the reported fluid leak issue.However, the investigation is inconclusive for the reported catheter expulsion as the exact circumstances at the time of the reported event are unknown.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: b5, d4 (expiry date: 11/2022).H11: section a through f: the information provide 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: APHERESIS PORT
• 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: 16618190
• MDR Text Key: 312025269
• Report Number: 3006260740-2023-01012
• Device Sequence Number: 1
• Product Code: PTD
• UDI-Device Identifier: 00801741129438
• UDI-Public: (01)00801741129438
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K163001
• 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
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A710962
• Device Catalogue Number: A710962
• Device Lot Number: REFV0472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• 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
• Patient Outcome(s): Required Intervention