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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SYRINGE INTEGRA W/NDL 23X1 RB; SYRINGE WITH NEEEDLE
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BECTON DICKINSON MEDICAL SYSTEMS BD¿ SYRINGE INTEGRA W/NDL 23X1 RB; SYRINGE WITH NEEEDLE Back to Search Results
Catalog Number 305271
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Discomfort (2330)
Event Date 02/26/2018
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 the needle of a bd¿ syringe integra w/ndl 23x1 rb was pulled out of hub into injection site when patient's wife was giving him an injection in buttock.Patient's wife stated that she could not see the needle sticking out.Patient had an x-ray at banner health, but health facility could not locate the needle.Medical doctor did not recommend any follow up or prescribe any medication.Patient stated that he was discomfortable from the needle.Customer¿s verbatim: ¿ consumer stated his wife was giving him an injection in buttocks and the needle "shot" off into his injection site.Stated wife could see the needle sticking out.Consumer went to banner health in masa, az and had x-ray done.Stated health facility was not able to locate needle.Stated the doctor did not recommend any follow up and there was no ointment or medication prescribed.Stated he's just having discomfort from the needle.Stated never had issue before.Lot: 3206402, item: 305271, expiration date not available.Stated purchase syringes 2 weeks ago.Date of occurrence: (b)(6) 2019.Would prefer to have item number 309580 as replacement.¿.
 
Manufacturer Narrative
H.6.Investigation: investigation cannot be performed for reported defects of expired product.Batch #3206402 (305271) expired on 2018/07/31.Product was used past expiration date.Device history record review is not applicable for expired product.
 
Event Description
It was reported that the needle of a bd¿ syringe integra w/ndl 23x1 rb was pulled out of hub into injection site when patient's wife was giving him an injection in buttock.Patient's wife stated that she could not see the needle sticking out.Patient had an x-ray at banner health, but health facility could not locate the needle.Medical doctor did not recommend any follow up or prescribe any medication.Patient stated that he was discomfortable from the needle.Customer¿s verbatim: ¿ consumer stated his wife was giving him an injection in buttocks and the needle "shot" off into his injection site.Stated wife could see the needle sticking out.Consumer went to banner health in masa, az and had x-ray done.Stated health facility was not able to locate needle.Stated the doctor did not recommend any follow up and there was no ointment or medication prescribed.Stated he's just having discomfort from the needle.Stated never had issue before.Lot: 3206402, item: 305271, expiration date not available.Stated purchase syringes 2 weeks ago.Date of occurrence: (b)(6) 2019.Would prefer to have item number 309580 as replacement.¿.
 
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Brand Name
BD¿ SYRINGE INTEGRA W/NDL 23X1 RB
Type of Device
SYRINGE WITH NEEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key8428840
MDR Text Key139079825
Report Number1213809-2019-00351
Device Sequence Number1
Product Code MEG
UDI-Device Identifier30382903052715
UDI-Public30382903052715
Combination Product (y/n)N
PMA/PMN Number
K011103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 05/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/31/2018
Device Catalogue Number305271
Device Lot Number3206402
Date Manufacturer Received02/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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