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

Catalog Number	405180
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: three (3) photos were provided by the customer for this investigation.It is observed a needle out of the blister showing a hair at the hub.No actual samples were received for this complaint.Based on the investigation the defect was confirmed per evaluation of three (3) photos provided by the customer.However, it¿s source cannot be determined without an actual sample.The manufacturing records were reviewed for the incident lot and no discrepancy or non-conformance were identified that could have contributed to the reported condition.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd¿ spinal needle with quincke bevel experienced foreign matter in cannula.The following information was provided by the initial reporter: needle with foreign matter (hair).

• 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: 15245717
• Report Number: 2618282-2022-00044
• Device Sequence Number: 6389618
• Product Code: BSP
• UDI-Device Identifier: 00382904051808
• UDI-Public: 00382904051808
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2022

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: Other
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 405180
• Device Lot Number: 1145468
• 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: 07/26/2022
• Initial Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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