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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 20 SYRINGE 3ML LL PISTON SYRINGE

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BECTON DICKINSON MEDICAL (SINGAPORE) 20 SYRINGE 3ML LL PISTON SYRINGE Back to Search Results
Catalog Number 302113
Device Problems Break (1069); Leak/Splash (1354); Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter zip: (b)(6). Investigation summary: three photos were received by our quality team for evaluation. From the photos, barrel damage and printing rub off was observed. The syringe barrel damage could have occurred at the assembly machine. The probable root cause of the cracked barrel could be due to the air jet at the auto-reject station is out of position, which resulted to the part poor throw out. At the syringe assembly process, there is a rotary main assembly dial. During the transfer of the syringe product to the exerciser dial, the syringe may tilt and hit against the dial side guide and cause the part to be trapped / jammed. When there is a product trapped / jammed at the side guide, it leads to the subsequent syringe to rub against the jammed product and causes damage on the barrel body. However, if the air jet, located at the auto-reject station which used to blow off the part from dial pocket, is out of position, it will lead to poor part throw out and flow to the subsequent process. An air jet bracket has been fabricated and installed at the auto reject station to secure the air jet in position. Communication with the production technicians to raise awareness on the reported defect will occur. 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 20 syringe 3ml ll had damaged barrels with scale marking issues. The following information was provided by the initial reporter: "the client estimated that approximately 20 barrels were faulty. The returned syringes have holes, cracks and/or dents between the 1ml measurement and end of the syringe, however the severity of the damage varies. ".
 
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Brand Name20 SYRINGE 3ML LL
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 Key12550281
MDR Text Key274072223
Report Number8041187-2021-00873
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeAS
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 09/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302113
Device Lot Number0083777
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2020
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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