MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL S/SU 18GA 6IN QUINCKE; ANESTHESIA CONDUCTION NEEDLE

Model Number	408360
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during quality control testing a needle spinal s/su 18ga 6 in quincke was found to not allow reinsertion of the stylet into the needle.The following information was provided by the initial reporter: "here is a photograph of the bd packages and the lot number of the needle that failed qc.They received 2 lots and the first lot of 50 needles was used and passed our inspection test.For the second lot, there were 20 units received in two boxes.We opened one and did the inspection.The stylet wouldn't reinsert into the needle.So there are 19 unopened needles and the one that was used to inspect.As you can see, the randomly selected needle from that lot would not allow reinsertion into the needle.We reject the entire lot based on this result".
Event or Problem Description
It was reported that during quality control testing a needle spinal s/su 18ga 6in quincke was found to not allow reinsertion of the stylet into the needle.The following information was provided by the initial reporter: "here is a photograph of the bd packages and the lot number of the needle that failed qc.They received 2 lots and the first lot of 50 needles was used and passed our inspection test.For the second lot, there were 20 units received in two boxes.We opened one and did the inspection.The stylet wouldn't reinsert into the needle.So there are 19 unopened needles and the one that was used to inspect.As you can see, the randomly selected needle from that lot would not allow reinsertion into the needle.We reject the entire lot based on this result".
Additional Manufacturer Narrative
Investigation summary bd has been provided with a photos for catalog 408360 lot 8218560 to investigate for this record.Visual examination of the photo shows one 18ga cannula that the stylet is not fully inserted into the cannula.As a result, bd was able to verify the reported issue.The most probable root cause of the defect is the incorrect flare formation which contributed to the defective fit test condition.The assembly process of the spinal needles includes flaring of the cannula to increase retention force of the over molded hub.If the flaring process causes a distortion to the cannula, the stylet will enter with some difficulty.Also, if the pilot pin of the mold does not get a proper seal against the flared cannula, plastic will come inside, causing the same condition.Since lot was manufactured multiple improvements to avoid ¿fit¿ condition has been address.Tooling for this station are included in the preventive maintenance program which are inspected and replaced accordingly.

• Brand Name: NEEDLE SPINAL S/SU 18GA 6IN QUINCKE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9804542
• Report Number: 2618282-2020-00017
• Device Sequence Number: 10290079
• Product Code: BSP
• UDI-Device Identifier: 30382904083602
• UDI-Public: 30382904083602
• Combination Product (Y/N): N
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• 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: 08/31/2023
• Device Model Number: 408360
• Device Catalogue Number: 408360
• Device Lot Number: 8218560
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/09/2020
• 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