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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367300
Device Problems Shielding Failure (1568); Physical Resistance/Sticking (4012)
Patient Problem Needle Stick/Puncture (2462)
Event Date 02/08/2022
Event Type  Injury  
Event Description
It was reported when using the bd (b)(6) adapter, the user experienced a needlestick injury post use, after the safety shield failed.There is no reports on the status of the nurse.The following information was provided by the initial reporter.The customer stated: on my ward, a nurse pricked herself on a needle that had just been drawn with blood.The needle has a gray protective cover.However, it went off when removed.Which made the needle visible.The cover seemed to come off quite easily.Is this a complaint you hear often? because this incident has unpleasant consequences (the patient with whom the adapter was used was contagious) i still want to officially report it to bd as a complaint.The gray cover on the needle does not appear to be glued to the needle shaft.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd vacutainer® multiple sample luer adapter, the user experienced a needlestick injury post use, after the safety shield failed.There is no reports on the status of the nurse.The following information was provided by the initial reporter.The customer stated: on my ward, a nurse pricked herself on a needle that had just been drawn with blood.The needle has a gray protective cover.However, it went off when removed.Which made the needle visible.The cover seemed to come off quite easily.Is this a complaint you hear often? because this incident has unpleasant consequences (the patient with whom the adapter was used was contagious) i still want to officially report it to bd as a complaint.The gray cover on the needle does not appear to be glued to the needle shaft.
 
Manufacturer Narrative
H.6.Investigation: bd had not received samples, but a photo was provided for investigation.The photo was reviewed and the indicated failure mode for sleeve fall off was observed.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.This complaint has been confirmed for the indicated failure mode of sleeve fall off.Bd was not able to identify a root cause for the indicated failure mode.
 
Event Description
It was reported when using the bd vacutainer® multiple sample luer adapter, the user experienced a needlestick injury post use, after the safety shield failed.There is no reports on the status of the nurse.The following information was provided by the initial reporter.The customer stated: on my ward, a nurse pricked herself on a needle that had just been drawn with blood.The needle has a gray protective cover.However, it went off when removed.Which made the needle visible.The cover seemed to come off quite easily.Is this a complaint you hear often? because this incident has unpleasant consequences (the patient with whom the adapter was used was contagious) i still want to officially report it to bd as a complaint.The gray cover on the needle does not appear to be glued to the needle shaft.
 
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Brand Name
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
Manufacturer (Section G)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13552245
MDR Text Key285772873
Report Number1024879-2022-00090
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K991088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number367300
Device Lot Number1307379
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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