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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD 3ML SYRINGES LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE
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BECTON DICKINSON MEDICAL (SINGAPORE) BD 3ML SYRINGES LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 302119
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2021
Event Type  malfunction  
Event Description
It was reported that 3 bd 3ml syringes luer-lok tip with bd precisionglide needle had scale marking issues.The following information was provided by the initial reporter: "scale mark on the syringes appeared to be slanted.".
 
Manufacturer Narrative
Date of event: unknown.Investigation summary: one photo was received by our quality team for evaluation.From the photo, the team is unable to determine a slant scale line printing issue.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.The current controls in place to prevent this nonconformance include a qa outgoing 3 hourly visual inspection of 100 pieces for barrel scale printing and an in-process 2 hourly visual inspection of 100 pieces for barrel scale printing.As no sample was returned for further analysis, the root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
Manufacturer Narrative
Date of event: unknown.Investigation summary: one photo was received by our quality team for evaluation.From the photo, the team is unable to determine a slant scale line printing issue.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.The current controls in place to prevent this nonconformance include a qa outgoing 3 hourly visual inspection of 100 pieces for barrel scale printing and an in-process 2 hourly visual inspection of 100 pieces for barrel scale printing.As no sample was returned for further analysis, the root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that 3 bd 3ml syringes luer-lok tip with bd precisionglide needle had scale marking issues.The following information was provided by the initial reporter: "scale mark on the syringes appeared to be slanted.".
 
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Brand Name
BD 3ML SYRINGES LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
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 Key13289734
MDR Text Key286128841
Report Number8041187-2022-00010
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeTW
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
Report Date 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302119
Device Lot Number1165539
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/23/2021
Initial Date FDA Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2021
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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