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

Model Number 1295108FD

Device Problem Bent (1059)

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

Event Date 05/23/2018

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 manufacturer has received a photo sample and will be evaluated.Results are expected soon.A lot history review (lhr) of recp0364 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that during placement of the device the clinician retracted the stylet and the wire was severely bent at approx.3 cm mark.

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 kinked stylet is confirmed, however the cause is unknown.One photograph of a tls stylet was returned for evaluation.An initial visual observation of the photograph showed a nearly 90° angle bend near the middle of the distal, polyamide-coated section of the stylet.What appears to be blood residue was observed on the distal end of the stylet.The details and features of the kink in the stylet could not be clearly seen in the returned photograph; therefore the exact cause of the kink is currently unknown.Possible causes of a kinked tls stylet include forceful withdrawal or insertion of the stylet, not properly wetting the stylet prior to manipulation of the stylet, and exposure of the stylet past the distal end of the catheter.A lot history review (lhr) of recp0364 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that during placement of the device the clinician retracted the stylet and the wire was severely bent at approx.3 cm mark.

• Brand Name: POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7602607
• MDR Text Key: 111849313
• Report Number: 3006260740-2018-01378
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034626
• UDI-Public: (01)00801741034626
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

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: 1295108FD
• Device Catalogue Number: 1295108FD
• Device Lot Number: RECP0364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 06/12/2018
• Supplement Dates FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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