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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK¿ SYRINGE; PISTON SYRINGE
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BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK¿ SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 300144
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2022
Event Type  malfunction  
Event Description
It was reported that the bd luer-lok¿ syringe tip was found damaged when trying to connect it to the tubing.The following information was provided by the initial reporter: "unable to connect syringe to tubing as syringe tip is dented.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter e-mail: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: one photo was received by our quality team for evaluation.From the returned photo, the barrel tip was observed to be bent.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.From the returned photo, the team was able to confirm that the barrel tip was bent.However, as no sample was received, a root cause cannot be determined.
 
Event Description
It was reported that the bd luer-lok¿ syringe tip was found damaged when trying to connect it to the tubing.The following information was provided by the initial reporter: "unable to connect syringe to tubing as syringe tip is dented".
 
Event Description
It was reported that the bd luer-lok¿ syringe tip was found damaged when trying to connect it to the tubing.The following information was provided by the initial reporter: "unable to connect syringe to tubing as syringe tip is dented".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 28-feb-2023.H5: imdrf annex b grid: b01.H5.Imdrf annex c grid: c1601.H5.Imdrf annex d grid: d03.H6: investigation summary one photo was received by our quality team for evaluation.From the returned photo, the barrel tip was observed to be bent.One sample was later received for investigation.From the sample, the tip was observed to be bent.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Current quality controls include a daily quality assurance routine visual inspection to check for tip damage.There is also a three hourly outgoing inspection and two hourly in-process inspection in place to check for damaged syringes.From the returned photo and sample, the team was able to confirm that the barrel tip was bent.The probable root cause could be due to the syringe assembled needle being stuck in between the conveyor gap at the unloading station.The causes the needle to press against the barrel tip and results in a bent barrel tip.
 
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Brand Name
BD LUER-LOK¿ SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15518944
MDR Text Key302341875
Report Number8041187-2022-00567
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903001446
UDI-Public(01)00382903001446
Combination Product (y/n)N
Reporter Country CodeMY
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,Followup
Report Date 03/28/2023
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 Number300144
Device Lot Number1333391
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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