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

Catalog Number	405081
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.¿.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2618282-2022-00050
• Device Sequence Number: 6002719
• Product Code: BSP
• UDI-Device Identifier: 00382904050818
• UDI-Public: 00382904050818
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K091758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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
• Operator of Device: Other
• Device Catalogue Number: 405081
• Device Lot Number: 2028704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown