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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP

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BECTON DICKINSON DE MEXICO BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP Back to Search Results
Catalog Number 309657
Device Problems Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2018
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 with the use of the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip there was an issue with a difficult plunger. It was stated ¿the customer reported that they were able to retract insulin into the syringe; however, when they attempted to remove the excess air they felt resistance. Customer removed the needle from the syringe and attempted to push the excess air out of the syringe; they were still not able to push the excess air from the syringe. ¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: sex: unknown event attributed to: other. Device single use?: no. Device returned to manufacture: yes.
 
Event Description
It was reported with the use of the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip there was an issue with a difficult plunger. It was stated ¿the customer reported that they were able to retract insulin into the syringe; however, when they attempted to remove the excess air they felt resistance. Customer removed the needle from the syringe and attempted to push the excess air out of the syringe; they were still not able to push the excess air from the syringe. ¿ there was no report of injury or further medical intervention.
 
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Brand NameBD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
MDR Report Key7563215
MDR Text Key110039881
Report Number9614033-2018-00032
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096573
UDI-Public30382903096573
Combination Product (y/n)N
PMA/PMN Number
K151766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup,Followup
Report Date 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2022
Device Catalogue Number309657
Device Lot Number7292574
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/01/2018 Patient Sequence Number: 1
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