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

Model Number 405180

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2020

Event Type  malfunction  

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 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".

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 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
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 10723559
• MDR Text Key: 214152601
• Report Number: 2618282-2020-00088
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904051809
• UDI-Public: 30382904051809
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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 Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other