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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 20ML LL PRECISE
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BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 20ML LL PRECISE Back to Search Results
Catalog Number 300141
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that there was an oily substance inside syringe with a bd syringe¿ 20ml ll precise.The following information was provided by the initial reporter: the user complained that obvious oily materials were found inside the syringe.Please help to check the unknown oily materials.Also, the user is concerning whether the syringe is safe to use.
 
Event Description
It was reported that there was an oily substance inside syringe with a bd syringe¿ 20ml ll precise.The following information was provided by the initial reporter: the user complained that obvious oily materials were found inside the syringe.Please help to check the unknown oily materials.Also, the user is concerning whether the syringe is safe to use.
 
Manufacturer Narrative
Investigation: photo evaluation: 1 photo and video were returned for evaluation.From the photo, observed a layer of coating on the rubber stopper.Sample evaluation: one actual sample returned for evaluation in open package and observed visible layer of coating on the rubber stopper.The layer of coating of fm from returned sample was sent for fourier transform infrared spectroscopy (ftir) test.The spectrum matches reasonably with a mixture of silicone and zinc stearate.The layer of coating of fm was compared with the silicone gel and silicone coating on the stopper.Silicone peaks on the layer of coating fm were found on the spectra of silicone gel and silicone coating on stopper.Probable cause could be at the assembly station, there was found excessive silicone during the production.The silicone gun and valve were replaced and housekeeping was performed at the area.Produced parts were verified silicone content test and within specification after corrective action before proceed with production.A dhr review was completed and no quality notification was raised in the past 12 months and routine silicon content records and results passed the outgoing inspection.
 
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Brand Name
BD SYRINGE 20ML LL PRECISE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key8485113
MDR Text Key141170541
Report Number8041187-2019-00281
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other,use
Type of Report Initial,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2023
Device Catalogue Number300141
Device Lot Number8201178
Date Manufacturer Received03/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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