MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN) (135 CM); PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2018
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 rebr0313 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that on (b)(6) 2018 the patient experienced a broken picc line.The picc was inserted on (b)(6) 2018.There was no reported patient injury.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 damaged catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 4 fr single lumen solo powerpicc.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 returned product sample was evaluated and a split was observed approximately 3.4 cm distal to the molded joint.The catheter split was typical of flexural fatigue, and the characteristics observed which supported this type of failure include: damage which was circumferentially aligned.Fracture edges which were rounded due to material wear.Impressions leading into and opposite of the fracture site which are consistent with material kinking.Overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing).The material around the fracture site was observed to be duller in luster than the rest of the catheter material.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.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.¿ a lot history review (lhr) of rebr0313 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that on (b)(6) 2018 the patient experienced a broken picc line.The picc was inserted on (b)(6) 2018.There was no reported patient injury.No other information was provided.

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN) (135 CM)
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7450640
• Report Number: 3006260740-2018-00787
• Device Sequence Number: 931523
• Product Code: LJS
• UDI-Device Identifier: 00801741027758
• UDI-Public: (01)00801741027758
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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: N/A
• Device Catalogue Number: 3194135
• Device Lot Number: REBR0313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1