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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ LUER-LOK SYRINGE; PISTON SYRINGE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ LUER-LOK SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 301035
Device Problems Leak/Splash (1354); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2022
Event Type  malfunction  
Event Description
It was reported that the tip of the bd¿ luer-lok syringe was damaged and caused it to leak.This occurred with 250 syringes.The following information was provided by the initial reporter, translated from german: "customer describes that there is a kind of web on the luer-lok connection, which causes it to leak".
 
Manufacturer Narrative
Investigation summary: it was reported the syringe molding was defective causing leakage.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos are magnified to show a visible tip flash.From the photos, it is not possible to confirm if the tip flash is out of specification.No other information could be obtained from the photos.A device history record review was completed for provided material number 301035, lot number 2040680.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with photo sample analysis the symptom reported by the customer could not be confirmed as what is shown in the photos could be an imperfection.Without the physical sample analysis a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 02-nov-2022.H6: investigation summary: it was reported the syringe molding was defective causing leakage.To aid in the investigation, five samples with no packaging blister, and two photos were provided for evaluation by our quality team.A visual inspection was performed and each syringe has a tip flash.Each tip flash was measured and all results were within specification.The photos are magnified to show a visible tip flash.From the photos, it is not possible to confirm if the tip flash is out of specification.No other information could be obtained from the photos.A device history record review was completed for provided material number 301035, lot number 2040680.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with returned sample analysis the symptom reported by the customer could not be confirmed, and a probable root cause could not be offered.
 
Event Description
It was reported that the tip of the bd¿ luer-lok syringe was damaged and caused it to leak.This occurred with 250 syringes.The following information was provided by the initial reporter, translated from german: "customer describes that there is a kind of web on the luer-lok connection, which causes it to leak".
 
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Brand Name
BD¿ LUER-LOK SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15518811
MDR Text Key301513415
Report Number1911916-2022-00545
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903010356
UDI-Public(01)00382903010356
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NA
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,Followup
Report Date 10/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301035
Device Lot Number2040680
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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