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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
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 redq4300 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the patient complained of pain.It was stated the picc was removed and found to have a fracture between the 4 and 5 cm line on the catheter.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter is confirmed, and the cause appears to be use related.One 4 fr single lumen powerpicc solo catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.A severe kink and a circumferential split were observed in the catheter between the 4 cm and 5 cm depth markers, approximately 5.7 cm distal to the molded joint.The 3, 4, and 5 cm depth markers were observed to be worn and faded.A microscopic observation revealed the edges of the split were rough but mostly straight, and additional, longitudinal splitting was observed at each corner of the split.The fracture surfaces of the split were found to have an uneven and granular texture.The surface of the catheter material was observed to be slightly less lustrous leading up to the edges of the split, and whitening of the catheter material was observed in a crease on the side opposite the split as well as at the corners of the split.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.¿ an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of redq4300 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the patient complained of pain.It was stated the picc was removed and found to have a fracture between the 4 and 5 cm line on the catheter.

• Brand Name: POWERPICC HF 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: 9411403
• Report Number: 3006260740-2019-03745
• Device Sequence Number: 11339418
• Product Code: LJS
• UDI-Device Identifier: 00801741152610
• UDI-Public: (01)00801741152610
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 01/13/2020

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: CK000827
• Device Lot Number: REDQ4300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1