MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROVPPSOLO 4FDL MBP; 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 Consequences Or Impact To Patient (2199)
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 redx1890 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "nitinol wire broken.Noticed when pulling line from patient.Failed placement." on 04/20/2020, additional information received stated, "picc attempt was made and it would not thread.When picc was pulled out with wire in place wire noticed to be broken at distal tip.".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged 3cg stylet was confirmed.One 3cg stylet was returned for investigation.The stylet was received within the t-lock extension set.A break in the polyimide tubing was observed 4.1cm from the distal tip of the stylet.The core wire extended 11mm from the break in the distal segment of the polyimide tubing.The core wire was curled just proximal to the polyimide tubing.Five kinks were observed within the proximal segment of polyimide tubing.Ten kinks were observed in the distal segment of polyimide tubing.The adjacent surfaces at the distal end of the broken polyimide tubing appeared uneven and granular.The wall thickness of the polyimide tubing was within specification.Kinking of the polyimide tubing and advancement against resistance may have been potential contributing factors in the observed damage; however, the exact cause of the reported event could not be determined.The ifu for the 3cg stylet states, ¿ensure that the stylet tip does not extend beyond the trimmed end of the catheter.Extension of the stylet tip beyond the catheter end, combined with kinking and excessive forces, may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and risk of patient injury.¿ a lot history review (lhr) of redx1890 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "nitinol wire broken.Noticed when pulling line from patient.Failed placement." 04/20/2020-additional information received stated, "picc attempt was made and it would not thread.When picc was pulled out with wire in place wire noticed to be broken at distal tip.".

• Brand Name: DOT PROVPPSOLO 4FDL MBP
• 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: 10032042
• Report Number: 3006260740-2020-01681
• Device Sequence Number: 2986774
• Product Code: LJS
• UDI-Device Identifier: 00801741154799
• UDI-Public: (01)00801741154799
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: S1294108D1
• Device Lot Number: REDX1890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1