MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	1275108FD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
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 device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) of rebz0887 showed no other similar product complaint(s) from this lot number.[mw5077662 (b)(4).Pdf].
Event or Problem Description
Facility reported that they had to replace a dl ft picc due to the picc fracturing at the junction between the picc and where the wings connect to the catheter.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 leaking catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 5fr d/l powerpicc catheter.The sample was received with needleless injection caps attached to both luer adapters and was attached to a statlock catheter stabilization device.Usage residues were observed throughout the sample.A longitudinally aligned split was observed just distal of the molded joint.A longitudinally aligned impression was observed circumferentially opposite the split.The sample kinked preferentially in the vicinity of the split during manual manipulation.An attempt to infuse water through the sample using a 12ml syringe revealed both lumens to be patent to infusion; however, when flushing the red-luered lumen, a leak was observed emanating from the site of the aforementioned split.Microscopic inspection of the split site revealed a granular fracture surface.The split site corresponded to the joint between the inner web wall and the outer catheter wall.Abundant adhesive residue was observed just distal of the split site.The preferential kinking, adhesive residue and split characteristics suggested that catheter kinking at near the catheter tubing/molded joint junction caused/contributed to the observed damage.It appeared that catheter kinking caused stress at the web wall/external wall junction, causing a tear in the catheter material.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 rebz0887 showed no other similar product complaint(s) from this lot number.Mw5077662.
Event or Problem Description
It was reported that the picc fractured at the junction between the picc and where the wings connect to the catheter.The catheter was removed and replaced.

• Brand Name: POWERPICC FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F
• 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: 7638529
• Report Number: 3006260740-2018-01497
• Device Sequence Number: 2376525
• Product Code: LJS
• UDI-Device Identifier: 00801741034572
• UDI-Public: (01)00801741034572
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/20/2018
• Report Date (Section F): 06/04/2018

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: 1275108FD
• Device Catalogue Number: 1275108FD
• Device Lot Number: REBZ0887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 07/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/04/2018