MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, DUAL-LUMEN, 12F; CHRONIC CATHETERS

Catalog Number	0600620
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
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.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 01/2027).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 or Problem Description
It was reported that two months post a chronic catheter palcement, a leakage was allegedly found just below the bifurcation of the catheter.Reportedly, the catheter was removed.There was no reported patient injury.
Event or Problem Description
It was reported that two months post a chronic catheter placement, a leakage was allegedly found just below the bifurcation of the catheter.Reportedly, the catheter was removed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one hickman d/l catheter was received for evaluation and three electronic photos were provided for review.Visual, microscopic, functional and tactile evaluations were performed.A partial compound break was noted on the catheter body, proximal to the bifurcate.Upon infusion, a leak from the compound break on the catheter body was observed while dye water exited the distal end of the catheter.Therefore, the investigation is confirmed for the reported fluid leak and the identified fracture issues and the photo review also confirms the same.The definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.(expiration date: 01/2027), 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: HICKMAN CV CATHETER, DUAL-LUMEN, 12F
• 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 SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18238842
• Report Number: 3006260740-2023-05441
• Device Sequence Number: 12508451
• Product Code: LJS
• UDI-Device Identifier: 00801741051913
• UDI-Public: (01)00801741051913
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0600620
• Device Lot Number: HUGW2194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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