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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LL PISTON SYRINGE Back to Search Results
Catalog Number 302113
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: two photos and one sample were received by our quality team for evaluation. From the photo, a visible layer of coating on the rubber stopper was observed. From the returned sample, the team observed visible lubrication residue on the rubber stopper. The sample was subjected to the silicone content test and was within specification. A device history record could not be evaluated as the lot number is unknown. From the returned observed visible lubrication (silicone) residue on the syringe rubber stopper. The silicone which was the only liquid material spray on the syringe barrel in the syringe assembly process is for easy withdrawal of the plunger. The sample passed the silicone content test and within specification, therefore the root cause could not be determined.
 
Event Description
It was reported when using the syringe 3ml ll there was foreign matter on device cannula/needle/syringe or any fluid path component. The following information was provided by the initial reporter. The customer stated: there was "excessive lubricant on the plunger in the syringe body. ".
 
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Brand NameSYRINGE 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 Key12557617
MDR Text Key274561815
Report Number8041187-2021-00878
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeKS
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 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302113
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
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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