MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F; 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	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, picc was broken in half at the suture wing.The rest of the picc was intact, but the extension legs and lumen were lying on the floor.They believe the patient could have interfered with the picc.Had to insert another picc." it was stated there was no harm to the patient.
Additional Manufacturer Narrative
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.The manufacturer has received the sample and will evaluate.Results are expected soon.
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; however, the root cause was not identified.The product returned for evaluation was one 5fr d/l powerpicc catheter.Usage residues were observed throughout the sample.The catheter was received in two segments which shared a complete break within the molded joint region, just proximal of the suture wings.Microscopic inspection of the break site revealed a dully granular fracture surface.Slight material flow was observed.No deformation or discoloration of the molded joint material was observed.Attempts to replicate the sample damage using a non-complainant catheter were unsuccessful.Those attempts resulted in severe discoloration and plastic deformation.The granular fracture surface was consistent with a tearing type failure of the material; however, attempts to replicate the damage were unsuccessful, suggesting that an additional factor(s) also contributed.Potential contributors include environmental factors affecting the mechanical properties of the catheter material.
Event or Problem Description
Picc was broken in half at the suture wing.The rest of the picc was intact, but the extension legs and lumen were lying on the floor.They believe the patient could have interfered with the picc.Had to insert another picc.It was stated there was no harm to the patient.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17004400
• Report Number: 3006260740-2023-02105
• Device Sequence Number: 7150792
• Product Code: LJS
• UDI-Device Identifier: 00801741034602
• UDI-Public: (01)00801741034602
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 1295108D
• Device Lot Number: REGZ0080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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