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

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that there was a hole in the catheter at 10 cm of length.No other information was provided.

Event Description

It was reported that there was a hole in the catheter at 10 cm of length.No other information was provided.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak was confirmed and appears to be related to the use of the device.One 4 fr sl powerpicc solo catheter was returned for investigation.The catheter extended up to the 39 cm depth marker.A horizontal ¿c¿ shaped split is visible near the 4 cm depth marker.Use residue is present throughout the device.Microscopic observation of the split revealed the catheter tubing to be compressed.The split corners propagated longitudinally.The split edges had matte discoloration which indicates repeated contact between the two split surfaces.The catheter was cut near the 5 cm depth marker and the dimensions were measured.The wall thickness and outer diameter were found to be within manufacturing specification.Based on the characteristics of the damage observed, the damage was likely cause due to repeated kinking of the catheter.The product instructions for use (ifu) states, "to minimize the risk of catheter breakage and embolization, the catheter must be secured in place" and "avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen." a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F
• Type of Device: 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: 8695344
• MDR Text Key: 148007350
• Report Number: 3006260740-2019-01639
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741138973
• UDI-Public: (01)00801741138973
• Combination Product (y/n): N
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2194108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1