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

Model Number	0600634
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2020
Type of Reportable Event	Malfunction
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: the sample was not returned for evaluation, however, one case study record was provided for review.The investigation is confirmed for the reported fracture issue.According to the case study record, approximately ten days post catheter placement, the subject developed an adverse event of catheter lumen torn during regular flushing.Subsequently, the study device was removed due to adverse event and the catheter was exchanged without any complication.The adverse event result in surgical intervention and recovered.Furthermore, the adverse event was not related to the procedure but definitely related to the study device.A definitive root cause could not be determined based upon 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: 04/2024).Device not returned.
Event or Problem Description
It was reported through the results of a clinical trial, approximately ten days post catheter placement, the patient developed adverse event of torn catheter lumen during regular flushing.The catheter was removed and exchanged.The current status of the patient is unknown.

• Brand Name: HICKMAN DUAL LUMEN CATHETER
• 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: 12414868
• Report Number: 3006260740-2021-03667
• Device Sequence Number: 3503586
• Product Code: LJS
• UDI-Device Identifier: 00801741051968
• UDI-Public: (01)00801741051968
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

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: 0600634
• Device Catalogue Number: 0600634
• Device Lot Number: HUDZ1370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 96