MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, SUBCLAVIAN

Model Number N/A

Device Problems Material Frayed (1262); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a j-tip guidewire.The visible portion of the wire extended from the straightener.Blood residue was observed on the wire and straightener.The distal tip of the wire was visible and appeared intact; however, the region between the j-tip and straightener appeared to be elongated, suggesting a break in the core wire.While damage was evident in the submitted photograph, inspection of the photograph was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include wire withdrawal against the introducer needle bevel and attempted insertion through a tortuous path.A lot history review (lhr) of reds4431 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the resistance was experienced during guide wire insertion.After removal, the guide wire tip was found split and which cause the insertion failure.No other information was provided.

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 initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.

Event Description

It was reported that the resistance was experienced during guide wire insertion.After removal, the guide wire tip was found split and which cause the insertion failure.No other information was provided.(b)(6)2020 - photo and returned sample showed a slight bend in the wire with no breaks or fractures in the wire.

• Brand Name: FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN)
• Type of Device: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9682335
• MDR Text Key: 194136132
• Report Number: 3006260740-2020-00435
• Device Sequence Number: 1
• Product Code: LFJ
• UDI-Device Identifier: 00801741066122
• UDI-Public: (01)00801741066122
• Combination Product (y/n): N
• PMA/PMN Number: K881743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• 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: 5678200
• Device Lot Number: REDS4431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1