MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4.5F MICROEZ UNIVERSAL PTFE MICROINTRODUCER SAFETY KIT; INTRODUCER, CATHETER

Model Number N/A

Device Problems Break (1069); Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

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 device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rebw1338 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.

Event Description

It was reported by the facility that the line was placed some time in (b)(6) 2017 and a piece of the guidewire broke off during the procedure.It was stated the migrated section has not been removed from the patient.No other information as been provided.

• Brand Name: 4.5F MICROEZ UNIVERSAL PTFE MICROINTRODUCER SAFETY KIT
• Type of Device: INTRODUCER, CATHETER
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7322488
• MDR Text Key: 101835134
• Report Number: 3006260740-2018-00397
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741038372
• UDI-Public: (01)00801741038372
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0678945
• Device Lot Number: REBW1338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention