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U.S. Department of Health and Human Services

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

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BD CARIBE LTD. NEEDLE SPINAL S/SU 18GA 6IN QUINCKE; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Model Number 408360
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/18/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event 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 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".
 
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.
 
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Brand Name
NEEDLE SPINAL S/SU 18GA 6IN QUINCKE
Type of Device
ANESTHESIA CONDUCTION NEEDLE
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
MDR Report Key9804542
MDR Text Key201940429
Report Number2618282-2020-00017
Device Sequence Number1
Product Code BSP
UDI-Device Identifier30382904083602
UDI-Public30382904083602
Combination Product (y/n)N
PMA/PMN Number
PREAMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,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 Received03/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2023
Device Model Number408360
Device Catalogue Number408360
Device Lot Number8218560
Was Device Available for Evaluation? No
Date Manufacturer Received02/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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