MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ ARTERIAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Model Number 408273

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/02/2022

Event Type  malfunction  

Event Description

It was reported that 4 bd¿ arterial needles broke during the puncture.The following information was provided by the initial reporter: "plastic part of the needle broke off during the puncturing.As a result, the metal part remained without a safety fuse (needle was removed by the help of wire)".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 4 bd¿ arterial needles broke during the puncture.The following information was provided by the initial reporter: "plastic part of the needle broke off during the puncturing.As a result, the metal part remained without a safety fuse (needle was removed by the help of wire)".

Manufacturer Narrative

H6: investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation and cannot verify the reported issue.A review of the device history record was performed, and no quality issues were found during production.Since an investigation could not be performed bd was unable to determine a possible root cause.H3 other text : see h10.

• Brand Name: BD¿ ARTERIAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15109363
• MDR Text Key: 297084831
• Report Number: 2618282-2022-00037
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904082735
• UDI-Public: 30382904082735
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

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
• Device Operator: Other
• Device Model Number: 408273
• Device Catalogue Number: 408273
• Device Lot Number: 1040702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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