MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4.5 FR UNIVERSAL MICRO INTRODUCER KIT WITH PTFE; CATHETER INTRODUCER

Catalog Number 0668945

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebq0963 showed no other similar product complaint(s) from this lot number.Device, not yet returned.

Event Description

It was reported by the nurse that the dilator and the peelable sheath were not easy to be separated when the dilator was withdrawn.No patient injury reported.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 dilator and sheath were difficult to split was unconfirmed.The reported problem could not be reproduced.One 4.5 fr x 5cm microintroducer was returned for investigation.The dilator was received within and treaded onto the sheath.No damage or defects were observed on the sample.Nothing remarkable was observed when the dilator hub was unthreaded from the sheath tabs.The dilator was removed from the sheath without any resistance.Skiving was present between the sheath tabs.The sheath tabs were split without difficulty and the sheath peeled uniformly and without resistance.Since the reported problem could not be replicated with a functional test, the complaint was unconfirmed.A lot history review (lhr) of rebq0963 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the nurse that the dilator and the peelable sheath were not easy to be separated when the dilator was withdrawn.No patient injury reported.

• Brand Name: 4.5 FR UNIVERSAL MICRO INTRODUCER KIT WITH PTFE
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6942627
• MDR Text Key: 90304002
• Report Number: 3006260740-2017-01815
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• 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: REBQ0963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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