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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE

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BECTON DICKINSON MEDICAL (SINGAPORE) BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 302149
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
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 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. 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. This incident has been added to our database of reported incidents.
 
Event Description
It was reported when using the bd plastipak¿ luer-lok¿ syringe 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 NameBD PLASTIPAK LUER-LOK SYRINGE
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 Key12556889
MDR Text Key274563014
Report Number8041187-2021-00876
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 09/14/2021
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 Number302149
Device Lot Number0359183
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2021
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
Date Device Manufactured12/24/2020
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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