MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TRIFUSION 19CM, INTERMEDIATE W/MI; CHRONIC CATHETERS

Model Number	0659190
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
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: one trifusion t/l catheter, one tunneler and one tunneler sheath in two pieces were returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported tunneler sheath broken issue, as a complete circumferential break was noted to the tunneler sheath that was elliptical in shape.Microscopic observation of the tunneler sheath revealed a ductile break which also appeared elliptical in shape.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: 05/2022).
Event or Problem Description
It was reported that during the catheter placement procedure, the tunneler sheath was allegedly broken.It was further reported that the physician removed the broken piece.There was no reported patient injury.

• Brand Name: TRIFUSION 19CM, INTERMEDIATE W/MI
• 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: 12370385
• Report Number: 3006260740-2021-03512
• Device Sequence Number: 3938810
• Product Code: LJS
• UDI-Device Identifier: 00801741036552
• UDI-Public: (01)00801741036552
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K041088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: 0659190
• Device Catalogue Number: 0659190
• Device Lot Number: REET1568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1