MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F DL POLYURETHANE CATHETER RADIOLOGY (135 CM NITINOL GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer "red lumen on 5f dual lumen picc broke off.The picc was placed in ir on (b)(6) 2023, catheter started leaking on (b)(6) 2023 and completely broke off on (b)(6).".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of 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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a damaged catheter was confirmed.The product returned for evaluation was one 5fr d/l powerpicc catheter.Usage residues were observed throughout the sample.The red luer adapter was completely detached and was not returned for evaluation.Kinks and curved shape memory were observed in both extension tubes.Microscopic inspection of the proximal end of the detached extension tubing revealed a granular fracture surface.Beach marks and radiating tear marks were observed throughout the fracture surface.Material buckling was observed in the vicinity of the break.The fracture features were consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to repetitive mechanical stress such as twisting and kinking which may gradually cause a crack(s) to form in the extension tubing material and may ultimately lead to material failure.
Event or Problem Description
It was reported by the customer "red lumen on 5f dual lumen picc broke off.The picc was placed in ir on (b)(6) 2023 catheter started leaking on (b)(6) 2023 and completely broke off on (b)(6).".

• Brand Name: POWERPICC 5F DL POLYURETHANE CATHETER RADIOLOGY (135 CM NITINOL GUIDEWIRE)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16820401
• Report Number: 3006260740-2023-01552
• Device Sequence Number: 12545649
• Product Code: LJS
• UDI-Device Identifier: 00801741027949
• UDI-Public: (01)00801741027949
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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 Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 3275335
• Device Lot Number: REFQ3574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown