MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 1174108D

Device Problems Difficult to Insert (1316); Material Integrity Problem (2978); Material Twisted/Bent (2981)

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

Event Date 08/22/2018

Event Type  malfunction  

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 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: two 3cg stylets were returned for investigation.It was implicated that the first stylet was used on a patient and the second stylet was used as a reference to measure the first stylet.Both stylets had been removed from the t-lock extension set.The product ifu states, ¿withdraw the entire t-lock connector/stylet assembly, as one unit.¿ a complete break was observed in the magnetic section of each stylet.A segment of polyimide tubing was missing from each stylet.On the first stylet, the polyimide tubing was received in two segments.The proximal segment was affixed to the core wire and was 2.7cm in length.The polyimide tubing was kinked 1.4cm from the proximal end of the tubing that was adhered to the core wire.The distal segment of the polyimide tubing was 2.0 cm in length and contained the conductive epoxy at the distal tip.A 2cm segment of core wire extended from the fractured end of the polyimide tubing at the proximal end of the distal stylet segment.A section of the polyimide tubing and magnets were missing from the middle of the stylet¿s magnetic tip.The core wire was kinked 2cm and 30cm from the distal end of the yellow tab.On the second stylet, the polyimide tubing was 5.2cm in length.A break was observed in the polyimide tubing and the distal segment of the stylet was not returned for investigation.Kinks were observed in the polyimide tubing.A microscopic examination revealed that the broken ends of the polyimide tubing were noted to be rough and uneven.Blood residue was observed within the polyimide tubing of the used sample.The wall thickness of the polyimide tubing was within specification for each sample.Due to the observed kinks and fractures in the polyimide tubing, the complaint was confirmed and the cause was determined to be related to use of the device.Placement of the catheter where kinking may occur should be avoided.Kinking of the stylet may result in stylet damage.A lot history review (lhr) of rect0834 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the rn inserted picc, unscrewed top and pulled wire back and it was stated it felt tight.Then the rn pulled the picc a little ways, and then reinserted the wire and lure locked the wire back in.The rn then inserted picc to svc, obtained cxr and inspected the wire post insertion.It was stated the end of the 3cg wire was bent in two places post insertion.The rn notice two weakened spots near the end of the wire (distal).It was said the wire sheared as the rn pulled it through ¿tougey¿.Returned were two wires, one was used to measure the reported wire.This report addresses the reported sheared wire.

• Brand Name: POWERPICC 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7899756
• MDR Text Key: 121580699
• Report Number: 3006260740-2018-02548
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034459
• UDI-Public: (01)00801741034459
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2018

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
• Device Operator: Health Professional
• Device Model Number: 1174108D
• Device Catalogue Number: 1174108D
• Device Lot Number: RECT0834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1