MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EXTERNAL CATHETER SEGMENT FOR HICKMAN 9F ROUND DUAL-LUMEN CV CATHETERS REPAIR KI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 0601700

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/02/2018

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 the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebr1214 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the nurse found the metal stent part to be movable after priming the product.Another device was used to complete the procedure.There was no patient injury reported.

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 that the stent moved was confirmed and it appeared that the movement was inadvertently caused during use.One repair segment was returned for investigation.The metal stents were positioned at the distal end of the repair segment.The distal tip of the larger stent was positioned approximately 1mm distal to the tip of the smaller stent.A red colored residue was observed on the metal stents.Tears were observed in the adhesive fillet at the distal end of the white tubing.Each lumen of the repair segment was patent to infusion and the metal stents did not move during infusion.The condition of the returned sample suggests that the catheter was damaged during use.The product ifu states, ¿note: if the replacement segment is to be cut to desired length, the splice connector stent can be removed and reinserted.¿ a lot history review (lhr) of rebr1214 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the nurse found the metal stent part to be movable after priming the product.Another device was used to complete the procedure.There was no patient injury reported.

• Brand Name: EXTERNAL CATHETER SEGMENT FOR HICKMAN 9F ROUND DUAL-LUMEN CV CATHETERS REPAIR KI
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7246315
• MDR Text Key: 99239597
• Report Number: 3006260740-2018-00142
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036439
• UDI-Public: (01)00801741036439
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K830406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 0601700
• Device Catalogue Number: 0601700
• Device Lot Number: REBR1214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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