MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F M; 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 recw1391 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when the rn started priming the line, he noticed that all was squirting all over.It was stated he trimmed the catheter and noted the line was inconsistently divided.
Event or Problem Description
It was reported that when the rn started priming the line, he noticed that all was squirting all over.It was stated he trimmed the catheter and noted the line was inconsistently divided.
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 damaged catheter was confirmed, and the damage appeared to be associated with use of the device.The catheter was apparently damaged during the catheter trimming process.One 5 fr d/l powerpicc ft catheter was returned for investigation.The picc was received with the t-lock extension set attached to the red connector.The stylet had been completely removed from the picc and t-lock extension set.The catheter tubing was received in four segments.The section of tubing that contained the 37 through 40cm depth markers was not returned for investigation.The segment of tubing containing the 40 through 49 cm depth markers appeared to be partially fused together at the proximal end (40cm mark).The catheter material around one lumen appeared to be fused together from the cutting process.Four small holes were visible in the fused material, which caused four streams of water to exit in different directions from the fused end of the tubing during a functional test.Attempts to replicate the fusion of the catheter material by trimming the tubing with assorted scissors were unsuccessful.The damage could be associated with dull scissors or an instrument that uses heat to cut.To modify the catheter length, the product ifu states, ¿using a sterile scalpel or scissors, carefully cut the catheter according to institutional policy if necessary.¿ the ifu also states, ¿inspect cut surface to assure there is no loose material.¿ the implicated kit contained scissors and a scalpel.

• Brand Name: POWERPICC FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F M
• 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: 8242143
• Report Number: 3006260740-2018-03864
• Device Sequence Number: 16714239
• Product Code: LJS
• UDI-Device Identifier: 00801741034572
• UDI-Public: (01)00801741034572
• 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: 1275108FD
• Device Lot Number: RECW1391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 01/11/2019
• 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