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

Model Number	S1395108D5
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reez2490 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported wire tip broke off and was unable to be located.Picc was dissected and nurse believes it got stuck in the valve.Took x-rays to see if it was in patient but it was not found.No other information was provided.
Event or Problem Description
It was reported wire tip broke off and was unable to be located.Picc was dissected and nurse believes it got stuck in the valve.Took x-rays to see if it was in patient but it was not found.No other information was provided.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken stylet is confirmed; however, the exact cause is unknown.One 3cg stylet was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal tip of the stylet was observed to be missing and the core wire could be seen protruding from the break site.Multiple bends were observed in the returned stylet.A microscopic observation revealed the break site was mostly straight but uneven, and the edges of the break were observed to be plastically deformed.The exposed magnet at the break site appeared to have been broken and two of the magnets proximal to the break appeared to have been broken as well.Kinks were observed in the polyimide tubing between each magnet and at the break sites of the broken magnets.The break site of the core wire of the stylet was curved and was observed to taper, which suggested that tensile (pulling) force was a factor in the event.The observed fracture features were indicative of catheter and/or stylet kinking, with tensile (pulling force), which likely occurred during the insertion process; however, the exact circumstances providing for that type of event were ultimately unknown.Evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA SOLO 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
• MDR Report Key: 11536704
• Report Number: 3006260740-2021-00925
• Device Sequence Number: 17084775
• Product Code: LJS
• UDI-Device Identifier: 00801741155222
• UDI-Public: (01)00801741155222
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: S1395108D5
• Device Catalogue Number: S1395108D5
• Device Lot Number: REEZ2490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 03/20/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other