MAUDE Adverse Event Report: BD CARIBE LTD. BD® QUINCKE SPINAL NEEDLES; ANESTHESIA CONDUCTION NEEDLE

Model Number	405181
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd® quincke spinal needles had foreign matter on the bevel side of the needle.The following information was provided by the initial reporter: there is a marking on the bevel side of the spinal needle.The physician feels the product is compromised.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd® quincke spinal needles had foreign matter on the bevel side of the needle.The following information was provided by the initial reporter: there is a marking on the bevel side of the spinal needle.The physician feels the product is compromised.
Additional Manufacturer Narrative
H6: investigation summary: there was no sample available but 2 photos were provided to bd for evaluation.Upon evaluation of the 2 photos, bd was able to confirm the reported issue.A review of the device history record was performed and no quality issues were found during production.A root cause could not be determined.

• Brand Name: BD® QUINCKE SPINAL NEEDLES
• Common Device Name: 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: 12963661
• Report Number: 2618282-2021-00074
• Device Sequence Number: 1854728
• Product Code: BSP
• UDI-Device Identifier: 30382904051816
• UDI-Public: 30382904051816
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 405181
• Device Catalogue Number: 405181
• Device Lot Number: 1236170
• 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: 11/09/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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
• Patient Sex: Unknown