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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD CARIBE LTD. BD QUINCKE SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE
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BD CARIBE LTD. BD QUINCKE SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Catalog Number 405181
Device Problem Complete Blockage (1094)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2020
Event Type  malfunction  
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 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 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.".
 
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.
 
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Brand Name
BD QUINCKE SPINAL NEEDLE
Type of Device
ANESTHESIA CONDUCTION NEEDLE
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
MDR Report Key9819436
MDR Text Key201941163
Report Number2618282-2020-00020
Device Sequence Number1
Product Code BSP
UDI-Device Identifier00382904051815
UDI-Public00382904051815
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number405181
Device Lot NumberUNKNOWN
Date Manufacturer Received02/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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