MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F; 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 device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recv2624 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported picc rn observed leaking from the picc insertion site.It was reported the clinician pulled the catheter and could see that it had split open around the 7cm mark.Also reported that the 8cm mark was missing/ not visible.
Event or Problem Description
It was reported picc rn observed leaking from the picc insertion site.It was reported the clinician pulled the catheter and could see that it had split open around the 7cm mark.Also reported that the 8cm mark was missing/ not visible.
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 split in the catheter is confirmed and was determined to be use related.One 4 fr single lumen powerpicc solo was returned for evaluation.An initial visual observation showed use residue on the returned sample.A circumferential split was observed in the catheter near the 7 cm depth marker.Some of the depth markers near and proximal the split were observed to be worn and faded.A microscopic observation revealed the edges of the split to be mostly straight with a rough surface texture.Whitening of the catheter material was observed at the corners of the split.An indentation was observed in the catheter at the 7 cm depth marker.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The product ifu states: ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F
• 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: 8418581
• Report Number: 3006260740-2019-00560
• Device Sequence Number: 11211578
• Product Code: LJS
• UDI-Device Identifier: 00801741034503
• UDI-Public: (01)00801741034503
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/27/2019

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: 1194108
• Device Lot Number: RECV2624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1