MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL S/SU 18GA 3-1/2IN QUINCKE; ANESTHESIA CONDUCTION NEEDLE

Model Number	405184
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
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 needle spinal s/su 18ga 3-1/2in quincke was used past the "12/2019" expiration date to "vent 20cc vials of red blood cells" while drawing them into a syringe.The defect was noticed during use.This occurred on 5 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: "we have a lot of spinal needles (4342766) that were used (5) past the expiration date.The expiration date was 12/2019." "they were used to vent 20cc vials of red blood cells, while drawing them into a syringe.".
Additional Manufacturer Narrative
H.6.Investigation: bd has not been provided with photos or samples for catalog 405184 lot 4342766 to investigate for this record.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.In this instance, catalog 405184 lot 4342766 the expiration date started at case, shelf and top web labels/identification is december 2019.This date correspond to a five years shelf life in which bd assures sterility and material stability / functionality.Bd does not recommend the usage after 5 years as stated on product expiration date.The reported issue does not represent a single significant incident that would trigger any corrective actions at this time.Dhr was performed, in process inspections according manufacturing record bdm1112 and final quality inspection record ifm1063 passed with satisfactory results.
Event or Problem Description
It was reported that the needle spinal s/su 18ga 3-1/2in quincke was used past the "12/2019" expiration date to "vent 20cc vials of red blood cells" while drawing them into a syringe.The defect was noticed during use.This occurred on 5 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: "we have a lot of spinal needles (4342766) that were used (5) past the expiration date.The expiration date was 12/2019." "they were used to vent 20cc vials of red blood cells, while drawing them into a syringe.".

• Brand Name: NEEDLE SPINAL S/SU 18GA 3-1/2IN QUINCKE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9781536
• Report Number: 2618282-2020-00015
• Device Sequence Number: 3384447
• Product Code: BSP
• UDI-Device Identifier: 30382904051847
• UDI-Public: 30382904051847
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (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): 03/25/2020

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2019
• Device Model Number: 405184
• Device Catalogue Number: 405184
• Device Lot Number: 4342766
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other