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

Model Number	0609230
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
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 as well as photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2022).
Event or Problem Description
It was reported that during dialysis catheter placement procedure, the tunneler allegedly had a break.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: one tunneler and one plastic tunneler sheath in two segments was returned for evaluation.Visual and microscopic visual evaluation were performed on the returned device.The investigation is confirmed for the reported fractured tunneler and identified material separation as complete circumferential break was noted on the tunneler plastic sheath.Further, the edges of the break on both pieces of the plastic covering were jagged and the break surface appeared to be smooth.A definitive root cause could not be determined, excessive procedural force could have potentially caused or contributed to the reported event.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: b5, d4 (expiry date: 08/2022).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.H3 other text : see h10.
Event or Problem Description
It was reported that during procedure through central venous catheter placement, the tunneler allegedly had a break.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: HICKMAN TRIFUSION CV CATHETER, TRIPLE-LUMEN, 12F
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11363941
• Report Number: 3006260740-2021-00428
• Device Sequence Number: 3443373
• Product Code: LJS
• UDI-Device Identifier: 00801741036538
• UDI-Public: (01)00801741036538
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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: 0609230
• Device Catalogue Number: 0609230
• Device Lot Number: REEW0424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Weight: 24