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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 recu2278 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a leak in 4fr red lumen was observed.No other information was provided.
Event or Problem Description
It was reported that a leak in 4fr red lumen was observed.No other information was provided.
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 red lumen of the 4fr powerpicc was inclusive due to the sample condition.One 4fr d/l powerpicc sv was returned for investigation.The catheter had been trimmed at the 30cm depth mark.Evidence of use was observed on the catheter.Tape residue was observed on the extension legs and non-vad extension sets were attached to each luer adaptor.A functional test revealed that each lumen of the catheter was patent to infusion.Under sustained hydraulic pressure, no leaks were observed in any part of the returned picc.The taper of the red luer adaptor was found to be out of specification.What caused the luer to be out of specification appears to be the forceful insertion of a male luer.Impressions from tooling were observed in the external surface of the red luer material.Deformation was also observed in the threads on the red luer adaptor.The forceful insertion of the extension set may have resulted in a gradual widening and deformation or the luer hub material over time.Whether the deformation of the luer caused or contributed to the leak could not be determined since a functional test revealed no leak in any part of the catheter.A review of the device history record (dhr) showed that the lot met all release criteria and no other complaints from this lot have been reported.

• Brand Name: POWERPICC SV 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: 8228941
• Report Number: 3006260740-2018-03838
• Device Sequence Number: 215965
• Product Code: LJS
• UDI-Device Identifier: 00801741087110
• UDI-Public: (01)00801741087110
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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: 1274108D
• Device Lot Number: RECU2278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/16/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1