MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLINE CV CATHETER, POLYURETHANE TRIPLE-LUMEN, 6F; CHRONIC CATHETERS

Model Number	0730615
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.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.Device not returned.
Event or Problem Description
It was reported that post device implant, the device allegedly fractured at the clamping sites.There was no reported patient injury.

• Brand Name: POWERLINE CV CATHETER, POLYURETHANE TRIPLE-LUMEN, 6F
• 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: 12405248
• Report Number: 3006260740-2021-03633
• Device Sequence Number: 17458089
• Product Code: LJS
• UDI-Device Identifier: 00801741036637
• UDI-Public: (01)00801741036637
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K093927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

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: 0730615
• Device Catalogue Number: 0730615
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1