MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL; NEEDLE, CONDUCTION, ANESTHETIC

Catalog Number 405081

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/01/2022

Event Type  Injury  

Event Description

It was reported that while using the bd¿ spinal needle with quincke bevel the needle was damaged during operation.The following information was provided by the initial reporter: spinal needle (sku 405081) has been damaged during operation.Describe patient / hcp / user impact: unidentified object (small piece) were found by x-ray in patient's body but no additional treatment from surgeon.

Manufacturer Narrative

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

Manufacturer Narrative

H6: investigation summary: one (1) photo was provided to bd for evaluation, cannula bent was confirmed through the photo provided as evidence for this investigation.Potential root cause can be directed to possible handling issues.As per complaint evidence has a notable bend on cannula in which can be an indicative to bending and repositioning.As it is explained in the ifu, this practice may increase the risk of needle breakage and therefore it is not recommended.The manufacturing facility has been notified of this incident and no discrepancy or non-conformance were identified that could have contributed to the reported condition.A review of the device history record was performed, and no quality issues were found during production.

Event Description

It was reported that while using the bd¿ spinal needle with quincke bevel the needle was damaged during operation.The following information was provided by the initial reporter: spinal needle (sku 405081) has been damaged during operation.Describe patient / hcp / user impact: unidentified object (small piece) were found by x-ray in patient's body but no additional treatment from surgeon.

• Brand Name: BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC
• 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: 15298377
• MDR Text Key: 298662858
• Report Number: 2618282-2022-00050
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00382904050818
• UDI-Public: 00382904050818
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K091758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 405081
• Device Lot Number: 2028704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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): Other