MAUDE Adverse Event Report: BD CARIBE LTD. BD® SPINAL NEEDLE 25 G X 3 1/2 IN. WITH QUINCKE BEVEL; ANESTHESIA CONDUCTION NEEDLE

Catalog Number	405180
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd® spinal needle 25 g x 3 1/2 in.With quincke bevel foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: quantity affected: 1 bx; serial/lot number: (b)(6); are any samples available for return? yes.Reported issue: perxxx: "we were informed that 3 spinal needles from lot# 3062941 had a metallic substance on the inside of the sterile packaging.
Event or Problem Description
It was reported while using bd® spinal needle 25 g x 3 1/2 in.With quincke bevel foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: quantity affected: 1 bx.Serial/lot number: (b)(6).Are any samples available for return? yes.Reported issue: perxxx: "we were informed that 3 spinal needles from lot# 3062941 had a metallic substance on the inside of the sterile packaging.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 28-jul-2023: h6: investigation summary: sample and photo received by our quality team for investigation.Through visual evaluation, seventeen (17) sealed blisters with unused needles were received in a plastic bag for material 405180 batch 3062941 from the customer for this investigation.One (1) sample (needle) provided it is observed what could be likely a part of a stylet sealed inside the blister with the needle.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.

• Brand Name: BD® SPINAL NEEDLE 25 G X 3 1/2 IN. WITH QUINCKE BEVEL
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17494140
• Report Number: 2618282-2023-00063
• Device Sequence Number: 15421826
• Product Code: BSP
• UDI-Device Identifier: 30382904051809
• UDI-Public: (01)30382904051809
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210978
• 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): 09/01/2023

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 Catalogue Number: 405180
• Device Lot Number: 3062941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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