MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERHICKMAN CV CATHETER, POLYURETHANE DUAL-LUMEN, 9.5F; CHRONIC CATHETERS

Catalog Number	0805910
Medical Device Problem Codes	Difficult to Flush (1251); Reflux within Device (1522); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional 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.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 or Problem Description
It was reported that approximately eleven days post chronic catheter placement, the catheter allegedly had kinked upon removal.It was further reported that catheter had issues in both infusion and aspiration.Reportedly the infusion was pumped through one port and were backflowing through the other.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that approximately eleven days post a chronic catheter placement, the catheter allegedly had kinked upon removal.It was further reported that catheter had issues in both infusion and aspiration.Reportedly, the infusion was pumped through one port and were backflowing through the other.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one 9.5fr power hickman d/l catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.An in-house syringe with dye water was attached to the red luer.The luer was patent to infusion as water successfully exited the distal end.Aspiration was attempted and was unsuccessful as only air was returned within the attached in-house syringe.Therefore, the investigation is confirmed for the reported suction issues.However, it is inconclusive for the reported reflux within device and difficult to flush as the provided evidence could not replicate the reported failure.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier (udi) #), g3, h4, h6 (method, result, conclusion).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: POWERHICKMAN CV CATHETER, POLYURETHANE DUAL-LUMEN, 9.5F
• Common Device Name: CHRONIC CATHETERS
• 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: 21846216
• Report Number: 3006260740-2025-02377
• Device Sequence Number: 21202774
• Product Code: LJS
• UDI-Device Identifier: 00801741036682
• UDI-Public: (01)00801741036682(11)240306(17)251130(10)REJN1022
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K061179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 0805910
• Device Lot Number: REJN1022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown