MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SOLO VALVE TECH SHERLOCK TPS 5F TL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by healthcare professional "last wednesday i was placing a picc line in ctu, and after the picc line was placed we checked the stylet wire, and it was bent in a 90 degree angle.There was no resistant and the catheter went down smoothly.The wire was not coiled or bent in any way, just the tip was bent when we checked it after placing the picc line.Barely touched the tip afterwards to check it, and it broke off." were all the missing/broken pieces retrieved and accounted for? yes.Was there any patient harm reported? no.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refx4410 showed no other similar product complaint(s) from this lot number.
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.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a fractured stylet is confirmed but the exact cause remains unknown.One photo sample of the distal end of a tls stylet was provided for evaluation.The product sticker label indicates lot: refx4410.A complete break is present proximal to the distal tip of the stylet.A slight curve in the stylet is also visible proximal to the break location.The surface characteristics of the damaged region could not be closely inspected from the image provided.The event description indicates the fracturing of the wire occurred during handling after noticing a bend after removal.Based on the information provided, possible contributing factors include advancement against resistance and bending of the wire during handling.Since the component was observed to be fractured in the image provided, the complaint is confirmed but the exact factors remain unknown.
Event or Problem Description
It was reported by healthcare professional "last wednesday i was placing a picc line in ctu, and after the picc line was placed we checked the stylet wire, and it was bent in a 90 degree angle.There was no resistant and the catheter went down smoothly.The wire was not coiled or bent in any way, just the tip was bent when we checked it after placing the picc line.Barely touched the tip afterwards to check it, and it broke off." were all the missing/broken pieces retrieved and accounted for? yes.1.Was there any patient harm reported? no.

• Brand Name: POWERPICC CATHETER WITH SOLO VALVE TECH SHERLOCK TPS 5F TL
• 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: 13895529
• Report Number: 3006260740-2022-00956
• Device Sequence Number: 14570399
• Product Code: LJS
• UDI-Device Identifier: 00801741112751
• UDI-Public: (01)00801741112751
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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: N/A
• Device Catalogue Number: S1395108D
• Device Lot Number: REFX4410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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