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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 Problems Break (1069); Leak/Splash (1354); Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined. A device history record could not be evaluated as the lot number is unknown. Complaints received for this product and condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the syringe 1ml ls tuberculin barrel was cracked and the scale markings were partially missing. The following information was provided by the initial reporter, translated from (b)(6) to english: "the customer uses this product for covid vaccination. Damaged barrel: the barrel was deformed. Scale marking issue: the scale was partially missing. ".
 
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Brand NameSYRINGE 1ML LS TUBERCULIN
Type of DevicePISTON 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 Key12310656
MDR Text Key266177990
Report Number8041187-2021-00711
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,Followup
Report Date 08/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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