MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 3CG TPS 5F BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	1295118
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
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 (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty inserting a microintroducer is confirmed; however, the exact cause is unknown.One 5.0 fr x 7 cm microintroducer was returned for evaluation.An initial visual observation showed use residue on the returned sample.The entire length of the microintroducer was observed to be curved.The distal tip of the sheath was observed to be damaged.A microscopic observation revealed one edge of the distal tip of the introducer sheath was buckled and folded with plastic deformation at the corners of the fold.No damage was observed on the distal tip of the dilator.While the cause of the damage observed on the introducer sheath tip is unknown, possible causes include damage during handling or use.A lot history review (lhr) of reer1121 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the micro-introducers are not as easy to insert.It was further reported that if the staff has difficulty advancing it into the skin, they may have to try again with a different one from a separate kit.The microez microintroducer 5.0 f with vessel dilator were in the powerpicc solo catheter with sherlock 3cg tip positioning system stylet insertion package.06/24/2021: the returned microintroducer was found to be buckled and folded.

• Brand Name: POWERPICC SOLO 3CG TPS 5F BASIC TRAY
• 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: 12184340
• Report Number: 3006260740-2021-02813
• Device Sequence Number: 4425035
• Product Code: LJS
• UDI-Device Identifier: 00801741034633
• UDI-Public: (01)00801741034633
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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 Expiration Date: 07/31/2021
• Device Model Number: 1295118
• Device Catalogue Number: 1295118
• Device Lot Number: REER1121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/16/2021
• 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