MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135CM NITINOL GUI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redz0074 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the peel away portion of the introducer was stuck, rendering it ineffective and a separate introducer was opened to complete the procedure.
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 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 damaged microintroducer is confirmed; however, the exact cause is unknown.One 5.0 fr x 10 cm microintroducer was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal tip of the sheath was observed to be damaged, and the dilator was observed to be curved.A microscopic observation revealed one edge of the tip of the introducer sheath was folded inward and plastically deformed at both corners of the fold.Some wrinkling was observed in the sheath material on the proximal side of the fold in sheath tip.No damage was observed on the dilator tip.While the root cause of the damage observed on the introducer sheath is unknown, possible causes include damage during handling or use.A lot history review (lhr) of redz0074 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the peel away portion of the introducer was stuck, rendering it ineffective and a separate introducer was opened to complete the procedure.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135CM NITINOL GUI
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10005973
• Report Number: 3006260740-2020-01524
• Device Sequence Number: 2740793
• Product Code: LJS
• UDI-Device Identifier: 00801741028120
• UDI-Public: (01)00801741028120
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• 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): 06/03/2020

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: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 3295335
• Device Lot Number: REDZ0074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1