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

Catalog Number 1716070J

Device Problems Reflux within Device (1522); Failure to Infuse (2340); Obstruction of Flow (2423)

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

Event Date 04/03/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the powerport slim implantable port, chronoflex single-lumen, kit, 6f that are cleared in the us.The pro code and 510 k number for the powerport slim implantable port, chronoflex single-lumen, kit, 6f are identified in procode and date rec¿d by mfr.

Event Description

It was reported that post port placement, the device allegedly had blood backflow, infusion issue and catheter occlusion problem.There was no reported patient injury.

Manufacturer Narrative

H10: the initial mdr mfg report #3006260740-2021-01966 submitted to fda captured three different events occurred on three different dates.Upon further review, the events were separated and processed in three different complaints (b)(4).However, the first event will remain in this report and the remaining two events were reported to fda under mfg report # 3006260740-2021-03693 and 3006260740-2021-03682.Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one ti power port slim with attached catheter was returned for evaluation.Functional, gross and microscopic visual evaluation were performed.During functional evaluation, upon infusing the port body and attached catheter segment only droplets were noted exiting from the distal end of the catheter.Further pressure was applied on the syringe resulting in blood residue exiting out of the catheter.Therefore, the investigation is inconclusive for the reported blood backflow and obstruction of flow issue as the exact circumstances at the time of the reported event are unknown and could not be reproduced in the lab.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: the catalog number identified in section d4 has not been cleared in the us but is similar to the power port slim implantable port, chronoflex single-lumen, kit, 6f that are cleared in the us.The pro code and 510 k number for the power port slim implantable port, chronoflex single-lumen, kit, 6f are identified in d2 and g4.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.

Event Description

It was reported that approximately one month and ten days post port placement, the device allegedly had blood backflow and catheter occlusion problem.There was no reported patient injury.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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
• MDR Report Key: 11869460
• MDR Text Key: 252154125
• Report Number: 3006260740-2021-01966
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• PMA/PMN Number: K072549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1716070J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other