MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM; CATHETER INTRODUCER

Catalog Number 0668945

Device Problems Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2018

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 rebw0719 showed two other similar product complaint(s) from this lot number.

Event Description

It was reported that three devices had hairs in them and were not smooth.There was no patient involvement.This file addresses the second of the three devices.

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 damaged guidewire with subsequent difficulty inserting the microintroducer was confirmed, but the exact cause was not determined.Open microintroducer kits from lot rebw0719 were returned for investigation.The guidewire, microintroducer, and introducer needle appeared to be unused.The guidewire was received in the hoop and the blue tip straightener was still attached.The guidewire was microscopically examined.Dislocations were observed in adjacent coils at the proximal end of the guidewire, which was positioned within the hoop.A translucent reside was observed between the dislocations in the coil wires.No hairs were observed on the wire.The grind pattern on the coil wire was misaligned, which indicates that the dislocations occurred after the guidewire was manufactured.The distal tip of the guidewire, which was positioned within the blue tip straightener showed no dislocations in the coil wire.A tactual investigation revealed that the weld tip on the guidewire was intact.An attempt was made to pass the distal tip of the microintroducer over the proximal end of the guidewire, but resistance was noted due to the increased cross sectional area caused by the dislocations in the coil wire.The outside diameter of the guidewire, away from the dislocated coil wire, was within specification.The guidewire was forwarded to the manufacturing facility for further review.Reynosa evaluation: the complaint of ¿the guidewire having hairs in the distal tip¿ is confirmed but the exact cause is unknown.According to the visual and microscopic evaluation the guidewire do not show hairs on the distal tip just the dislocation that were observed in adjacent coils at the proximal end of the guidewire but the outside diameter of the guidewire was within the specification, the cause of this condition is unknown.A lot history review (lhr) of rebw0719 showed two other similar product complaint(s) from this lot number.

Event Description

It was reported that three devices had hairs in them and were not smooth.There was no patient involvement.This file addresses the second of the three devices.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM
• Type of Device: CATHETER INTRODUCER
• 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7404134
• MDR Text Key: 104694322
• Report Number: 3006260740-2018-00645
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741074530
• UDI-Public: (01)00801741074530
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0668945
• Device Lot Number: REBW0719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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