MAUDE Adverse Event Report: BD CARIBE LTD. BD QUINCKE SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number	405181
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd¿ quincke spinal needle clogged during use while piercing a silicone diaphragm, with the silicone plugging up the needle and preventing an equal exchange of gasses.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "one is straightforward 1 inch 21 gauge, it's the larger needle i'm having trouble figuring out.We use the two to replace the headspace gasses of vials, so the longer needle is the vent tube that goes to the bottom of the vial, while the shorter needle is connected to the large syringe and injects the new gas.We have issues with both of them clogging, as we use them to pierce a silicon diaphragm, and after some time the silicon plugs up the needle, preventing an equal exchange of gasses.We used to have an even thinner long needle that was clogged that we used to push out the silicon plugs from the vent needle, but it got thrown out accidentally.We use a luer-lock connection for these as well.".
Event or Problem Description
It was reported that the bd¿ quincke spinal needle clogged during use while piercing a silicone diaphragm, with the silicone plugging up the needle and preventing an equal exchange of gasses.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "one is straightforward 1 inch 21 gauge, it's the larger needle i'm having trouble figuring out.We use the two to replace the headspace gasses of vials, so the longer needle is the vent tube that goes to the bottom of the vial, while the shorter needle is connected to the large syringe and injects the new gas.We have issues with both of them clogging, as we use them to pierce a silicon diaphragm, and after some time the silicon plugs up the needle, preventing an equal exchange of gasses.We used to have an even thinner long needle that was clogged that we used to push out the silicon plugs from the vent needle, but it got thrown out accidentally.We use a luer-lock connection for these as well.".
Additional Manufacturer Narrative
H.6.Investigation summary bd has not been provided with photos or samples for catalog 405181 to investigate for this record.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.Failures for clogged cannulas can be related to stations 8 of tics machine in which condition can be associated to material getting into the cannula blocking cannula inside diameter.As a result, needles cannot complete their assemble process.The reported issue does not represent a single significant incident that would trigger any corrective actions at this time.A device history review could not be completed as no batch number was provided.

• Brand Name: BD QUINCKE SPINAL NEEDLE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9819436
• Report Number: 2618282-2020-00020
• Device Sequence Number: 2764973
• Product Code: BSP
• UDI-Device Identifier: 00382904051815
• UDI-Public: 00382904051815
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• 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 Catalogue Number: 405181
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/11/2020
• 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