MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NITINOL CORE GUIDEWIRE, .035", 3 CM, STRAIGHT, STIFF, 150 CM LENGTH

Model Number 150NSS35

Device Problem Component Missing (2306)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the one entire box was opened when the products were put in hospital stock.It was reported that one guide wire was missing in one of the box with only nine guide wires present.

Event Description

It was reported that the one entire box was opened when the products were put in hospital stock.It was reported that one guide wire was missing in one of the box with only nine guide wires present.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause of the reported event could be that the "inadequate retention".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• Brand Name: NITINOL CORE GUIDEWIRE, .035", 3 CM, STRAIGHT, STIFF, 150 CM LENGTH
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11345407
• MDR Text Key: 232524294
• Report Number: 1018233-2021-00647
• Device Sequence Number: 1
• Product Code: EZB
• UDI-Device Identifier: 00801741051524
• UDI-Public: (01)00801741051524
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 150NSS35
• Device Catalogue Number: 150NSS35
• Device Lot Number: NGDZ1477
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other