MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN HEMODIALYSIS/APHERESIS CATHETER, DUAL-LUMEN, 13.5F; CHRONIC CATHETER

Model Number	0600660
Medical Device Problem Codes	Difficult to Flush (1251); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(expiry date: 11/2023).
Event or Problem Description
It was reported that during preparation of dialysis catheter implant procedure, the puncture needle allegedly cannot rinse.The procedure was completed using another device.There was no patient contact.
Event or Problem Description
It was reported that during preparation of dialysis catheter implant procedure, the puncture needle allegedly cannot rinse.The procedure was completed using another device.There was no patient contact.
Additional 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 13.5fr hickman d/l catheter, one introducer needle, one guidewire straightener loaded to a j-tip guidewire in a guidewire hoop, one syringe, one 14.0fr introducer peel-apart sheath and vessel dilator, two end caps and one suture wing were returned for evaluation.Gross visual, microscopic visual and functional testing were performed.The investigation is confirmed for the reported difficulty in flushing issue and identified fracture issue as small cracks were noted within the introducer needle hub.Upon infusion, small drops of water was observed exiting the introducer needle hub while exiting the distal end.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.(expiry date: 11/2023).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: HICKMAN HEMODIALYSIS/APHERESIS CATHETER, DUAL-LUMEN, 13.5F
• Common Device Name: CHRONIC CATHETER
• 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: 15138224
• Report Number: 3006260740-2022-02994
• Device Sequence Number: 20234203
• Product Code: LJS
• UDI-Device Identifier: 00801741037504
• UDI-Public: (01)00801741037504
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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 Model Number: 0600660
• Device Catalogue Number: 0600660
• Device Lot Number: REFN1534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• 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