MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	CK000525A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recs2467 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported powerpicc solo was torn at base of catheter out of sterile package.It was not used on patient.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak in the picc was confirmed and the location of the leak coincided with a manufactured cut in the molded bifurcation.One 5fr d/l powerpicc solo ft was returned for investigation.The stylet had been removed from the catheter and was not returned for investigation.Injection caps were attached to the solo connectors.The label with the product code and lot #recs2467 was attached to the extension legs.The d/l tubing had been cut in the marked no trim zone 4.1cm distal to the 25cm depth mark.A functional test revealed a leak in the d/l tubing at the distal end of the bifurcation.The leak site was microscopically examined and a breach was observed in the tubing that coincided with the trimmed end of the flash from the molded bifurcation.It appears that the leak site developed as a result of the flash trimming process.Whether the catheter was fully breached at the time the flash was trimmed is unknown.The hole in the tubing may have developed over time if the catheter was nicked at the time the flash was trimmed.The complaint was forwarded to the manufacturing facility for further review.A lot history review (lhr) of recs2467 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported powerpicc solo was torn at base of catheter out of sterile package.It was not used on patient.

• Brand Name: POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 7896182
• Report Number: 3006260740-2018-02528
• Device Sequence Number: 1394515
• Product Code: LJS
• UDI-Device Identifier: 00801741124075
• UDI-Public: (01)00801741124075
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 11/04/2018

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: CK000525A
• Device Catalogue Number: CK000525A
• Device Lot Number: RECS2467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1