MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WITH MIC; 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)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the placer noticed through x-ray a problem with the wire- removed picc slowly and was able to clamp off the dangling end of the stylet and successfully removed.Patient was not harmed and was discharged the same day.The picc was placed in the right arm, new picc placed in opposite arm.
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 frayed stylet is confirmed but the exact cause and factors leading to the event remain unknown.One 5 fr dl powerpicc catheter, kit components, and two tls stylets were returned for investigation.A 5 cm fractured tls segment was also returned.The catheter was observed to be trimmed at the 38 cm depth marker.Evidence of use was observed throughout the returned components.Microscopic observation of the first stylet revealed it to be frayed.Kinks in the polyimide tubing were observed near the distal end.The kinks appeared to be preferentially located in between magnet locations.The second tls stylet did not appear to be frayed or kinked.The wall thickness of the polyimide tubing was measured for both samples and both were found to be within manufacturing specification.The presence of kinks prior to the fracture location suggest the stylet was exposed to resistance which likely led to the kinking and fracturing.Extension of the stylet beyond the catheter may also lead to fracturing.The product instructions for use (ifu) 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 may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and/or risk of patient injury." a lot history review (lhr) of redx0600 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the placer noticed through x-ray a problem with the wire- removed picc slowly and was able to clamp off the dangling end of the stylet and successfully removed.Patient was not harmed and was discharged the same day.The picc was placed in the right arm, new picc placed in opposite arm.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WITH MIC
• 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: 9878738
• Report Number: 3006260740-2020-01010
• Device Sequence Number: 3752082
• Product Code: LJS
• UDI-Device Identifier: 00801741035692
• UDI-Public: (01)00801741035692
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• 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): 05/01/2020

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 Model Number: N/A
• Device Catalogue Number: 9275108D
• Device Lot Number: REDX0600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 58