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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample analysis, applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged punctured sheath was confirmed but the exact cause is unknown.The product return for evaluation was a powerpicc 5fr solo2 microintroducer dilator/sheath.The sample was returned with dilator within the sheath.Further, evaluation also confirmed that the sample has been used and there is a presence of a crumpled region of sheath at the distal edge.Microscopic examination of that sheath showed that the damage region contained two points of apparent contact and evidence that a force had been applied to pull that region of sheath towards the proximal end.Further examination of the sheath/dilator region found that the transition between the two components appeared to be normally formed and unremarkable.Insufficient evidence was observed to confirm the exact nature of the damage seen but possible causes could be an insertion angle which was too great or failure to twist the introducer set upon advancement into the insertion site in conjunction with the edge of the sheath being caught on hard fascia or tissue.A lot history review (lhr) of reez3473 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by healthcare professional "our infusion nurse was inserting a picc this morning that had a faulty introducer; the end is rolled just slightly.They had to open another kit to complete procedure." no other information was provided.(b)(6) 2021: during evaluation the returned device was noted to be crumpled at the distal edge.

• Brand Name: POWERPICC SOLO FT CATHETER 5F MAX BARRIER TRAY (DL)
• 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: 12392011
• Report Number: 3006260740-2021-03615
• Device Sequence Number: 14792405
• Product Code: LJS
• UDI-Device Identifier: 00801741028076
• UDI-Public: (01)00801741028076
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 08/11/2021

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: N/A
• Device Catalogue Number: 3295108FD
• Device Lot Number: REEZ3473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 08/31/2021
• 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