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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 1ML LS TUBERCULIN; PISTON SYRINGE

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BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 1ML LS TUBERCULIN; PISTON SYRINGE Back to Search Results
Catalog Number 302100
Device Problem Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: one photo was received by our quality team for evaluation.From the photo, barrel tip damage was observed.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The team investigated different sections of the syringe machine and matched a potential area which could lead to the reported defect.The syringe barrel tip damage could have occurred at the assembly machine.At the assembly process, there is an auto-reject station where the rejected syringe will be removed.The probable root cause of the damaged barrel tip could be due to the not being kicked out at the auto-reject station effectively.The syringe tip could have dislodged from the dial pocket and hit against the guide skirt; however, the barrel flange was stuck at the assembly dial.A new air-jet will be fabricated to improve the auto-reject station to increase air flow and improve proper kick-out of the rejected parts.Communication with the production technicians to raise awareness on the reported defected will also occur.This incident has been added to our database of reported incidents.
 
Event Description
It was reported when using the syringe 1ml ls tuberculin the product was damaged/deformed - device was operable.The following information was provided by the initial reporter.The customer stated: "the surface of the syringe (hub) was melted.".
 
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Brand Name
SYRINGE 1ML LS TUBERCULIN
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12416285
MDR Text Key271341075
Report Number8041187-2021-00792
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/20/2021
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 Number302100
Device Lot Number0167927
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/04/2021
Initial Date FDA Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2020
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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