MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE; ANESTHESIA CONDUCTION NEEDLE

Model Number	405180
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/29/2020
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.(b)(4).
Event or Problem Description
It was reported that 63 needles spinal s/su 25ga 3-1/2in quincke were found discolored before use.The following information was provided by the initial reporter: "reported issue: discoloration".
Additional Manufacturer Narrative
H6: investigation summary 63 samples were received by our quality team for evaluation.Upon visual inspection and evaluation of all 63 samples, it was observed that the samples were in product specification; therefore, the incident could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the investigation, the samples did not contain discoloration, variation in color, foreign matter, nor cloudiness condition and meet product specification requirements.Since the incident could not be verified a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 63 needles spinal s/su 25ga 3-1/2in quincke were found discolored before use.The following information was provided by the initial reporter: "reported issue: discoloration".

• Brand Name: NEEDLE SPINAL S/SU 25GA 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: 10723559
• Report Number: 2618282-2020-00088
• Device Sequence Number: 1679636
• Product Code: BSP
• UDI-Device Identifier: 30382904051809
• UDI-Public: 30382904051809
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2025
• Device Model Number: 405180
• Device Catalogue Number: 405180
• Device Lot Number: 0125473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 10/26/2020
• 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