MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MICROEZ MICROINTRODUCER KIT 4.5F (5CM, NITINOL); CATHETER INTRODUCER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 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 frayed guidewire is inconclusive due to poor sample condition.One photo sample of a microez introducer package label was returned for evaluation.An initial visual observation of the photo showed the product labeling of a microez introducer kit with ref#: 0738945 and lot#: rebu0288.The device is not visible in the photo provided.Based on the description of the reported complaint, possible contributing factors include kinked guidewire and needle damage to guidewire.As the complaint of a frayed guidewire cannot be confirmed based on the photo sample provided for evaluation, the complaint is inconclusive, poor sample condition.The ifu states ¿caution: if the guidewire must be withdrawn while the needle is inserted, remove both the needle and the wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ a lot history review (lhr) of rebu0288 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the facility had an issue with a guidewire shearing while inserting a midline.Another kit was used to complete the procedure.There was no reported patient harm.

• Brand Name: MICROEZ MICROINTRODUCER KIT 4.5F (5CM, NITINOL)
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7195369
• Report Number: 3006260740-2017-02439
• Device Sequence Number: 19203862
• Product Code: DYB
• UDI-Device Identifier: 00801741074622
• UDI-Public: (01)00801741074622
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K915167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0738945
• Device Lot Number: REBU0288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1