MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT STC PPICC, SOLO, 5FR; 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	03/16/2021
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 reex3359 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported picc nurse inserted picc in pt.And when stylet was removed from picc it was noted that stylet tip was bent and almost broken off.
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 damaged stylet is confirmed; however, the exact cause is unknown.One 3cg stylet was returned for evaluation.An initial visual observation showed some use residue on the returned sample.A bend was observed at the distal end of the stylet, approximately 2.5 cm proximal to the distal tip, and during handling of the sample, the stylet broke at this observed bend.Two additional bends were observed in the core wire of the stylet.A microscopic observation revealed the break in the polyimide tubing was jagged with an uneven surface texture.Delamination of the polyimide tubing was observed at the break site, and three kinks were observed in the polyimide tubing proximal to the break site.Measurements of the core wire, magnets, and polyimide wall thickness were all within specification.The observed fracture features were indicative of catheter and/or stylet kinking, which likely occurred during the insertion process.However, the exact circumstances providing for that type of event were ultimately unknown.
Event or Problem Description
It was reported picc nurse inserted picc in pt.And when stylet was removed from picc it was noted that stylet tip was bent and almost broken off.

• Brand Name: DOT STC PPICC, SOLO, 5FR
• 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: 11780483
• Report Number: 3006260740-2021-01672
• Device Sequence Number: 14361164
• Product Code: LJS
• UDI-Device Identifier: 00801741085727
• UDI-Public: (01)00801741085727
• 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: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: 1395118Q
• Device Lot Number: REEX3359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 04/10/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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