MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0602680

Device Problems Fracture (1260); Material Separation (1562); Failure to Advance (2524)

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

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, a video was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2026).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.

Event Description

It was reported that during a port placement procedure in the right subclavian vein, during the passage of the metal guide wire, the guide wire allegedly did not progress and showed a lot of resistance.Reportedly the needle and guide wire were removed and it was identified that the guide wire was apparently thicker than the jelco lumen.It was further reported that when forced, the guide wire was allegedly separated from its parts.There was no reported patient injury.

• Brand Name: M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• 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
• 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: 19085685
• MDR Text Key: 340687973
• Report Number: 3006260740-2024-01605
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025679
• UDI-Public: (01)00801741025679
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K873213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

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: 0602680
• Device Lot Number: REGR4500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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