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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; PISTON SYRINGE
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BECTON DICKINSON DE MEXICO BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP; PISTON SYRINGE Back to Search Results
Model Number 309657
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2021
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 2 bd luer-lok¿ disposable syringes with bd luer-lok¿ tip had air bubbles in them during use.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "bubbles in syringe, possible issue with tip.".
 
Event Description
It was reported that 2 bd luer-lok¿ disposable syringes with bd luer-lok¿ tip had air bubbles in them during use.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "bubbles in syringe, possible issue with tip".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/12/2021.H.6.Investigation: samples and photos received for investigation.16 physical samples from the customer were received which were sent to the quality control laboratory for inspection, based on visual and functional tests carried out, it can be concluding the following: there is no damage nor defect on the physical samples that could affect the product functionality, also, leakage test was performed, air bubbles generation were not detected, therefore defect reported by the customer is not confirmed.Furthermore, during the documentary review of the batch 0332006 no quality events record in the product manufacture were found, the batch was inspected and later released accordance with the valid work instruction.The defect was not confirmed, and the root cause could not be determined.Chc was performed and this is the 1st related complaint for air bubbles on the provided lot number 0332006.
 
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Brand Name
BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
MDR Report Key11815606
MDR Text Key250370192
Report Number9614033-2021-00053
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 other,user facility
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309657
Device Catalogue Number309657
Device Lot Number0332006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2021
Date Manufacturer Received06/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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