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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LS
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BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LS Back to Search Results
Catalog Number 302106
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/30/2021
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that syringe 3ml ls experienced 2 cases of molding defects -short shots on barrel, and 1 case of scale marking permanency.The following information was provided by the initial reporter: bowed barrel ×2: the barrel was deformed.Damaged barrel ×1: the outer surface of the barrel was rough and have burr(s).
 
Event Description
It was reported that syringe 3ml ls experienced 2 cases of molding defects -short shots on barrel, and 1 case of scale marking permanency.The following information was provided by the initial reporter: bowed barrel ×2: the barrel was deformed.Damaged barrel ×1: the outer surface of the barrel was rough and have burr(s).
 
Manufacturer Narrative
H6: investigation: two photos and three samples were received by our quality team for evaluation.From the photos, the barrel was observed to be damaged and bent (bowed).From the returned samples, barrel body damage causing a bent (bowed) barrel.A device history record could not be evaluated as the lot number is unknown.The probable root cause could be poor feeding of syringe product causing the barrel to be slanted when entering the leak test station dial pocket as a result of a part being caught/trapped.The subsequent parts are trapped/jammed at the main assembly dial machine.This might lead to the trapped part colliding or causing friction with the on-going production part, and it will cause the bent (bowed) barrel and damage on the barrel body.It is likely that the jammed parts were not effectively removed by the production technician resulting the damage part to flow to the subsequent process.H3 other text: see h10.
 
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Brand Name
SYRINGE 3ML LS
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key12385188
MDR Text Key268714563
Report Number8041187-2021-00780
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302106
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2021
Date Manufacturer Received09/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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