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 Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redq0625 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported that when flushing the catheter with saline there was a leakage from the insertion site.The catheter was withdrawn and when flushing it outside the patient there is a hole at 4.5 cm.The catheter was placed on (b)(6) 2019 and was 3 cm outside the patient and secured with securacath.Chemotherapy is given - folfox to the beginning of september and after that blood and tpn has been given in the catheter.

Manufacturer Narrative

H11:section a through f - the information provided by bd 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 bd.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 powerpicc solo catheter was returned for investigation.Evidence of use was present throughout the catheter.The sample was flushed with water using a 12 ml syringe and a leak was present near the 4 cm depth marker.A microscopic observation revealed a circumferential split at the 4 cm depth marker.The split was observed to have a rough and granular surface.Material whitening was present near the split edges.A section of the catheter appeared to be compressed near the 2 cm depth marker.The characteristics of the split suggest material fatigue caused by repeated kinking of the catheter is a likely contributing factor.The catheter was cut near the split location and the wall thickness was measured.The wall thickness was within manufacturing specification.The product instructions for use (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 redq0625 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported that when flushing the catheter with saline there was a leakage from the insertion site.The catheter was withdrawn and when flushing it outside the patient there is a hole at 4.5 cm.The catheter was placed (b)(6) 2019 and was 3 cm outside the patient and secured with securacath.Chemotherapy is given - folfox to the beginning of (b)(6) and after that blood and tpn has been given in the catheter.

• 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: 9519906
• MDR Text Key: 180640867
• Report Number: 3006260740-2019-04010
• 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: 02/04/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2194108
• Device Lot Number: REDQ0625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1