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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 50ML LL TIP 1ML; PISTON SYRINGE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 50ML LL TIP 1ML; PISTON SYRINGE Back to Search Results
Catalog Number 309653
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that syringe 50ml ll tip 1ml leaked.The following information was provided by the initial reporter: 50cc syringe filled with propofol then want to fill the perfusion line but the liquid flows at the back of the stopper.
 
Manufacturer Narrative
H.6.Investigation: it was reported the liquid flows at the back of the stopper.To aid in the investigation, one sample in an opened packaging blister and one photo was provided for evaluation by our quality team.A visual inspection was performed and there is a white solution between the stopper ribs about 1" long.There is no white solution past the rubber stopper.The sample was tested for air leakage and passed.The rubber stopper was taken out and measured finding the outside diameter was within specification.The internal diameter of the barrel was also measured finding it within specification as well.The photo provided shows a packaging blister top web with an empty syringe next to it.The rubber stopper is at the 18ml mark.A device history record review was completed for provided material number 309653, lot number 1056652.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.H3 other text : see h.10.
 
Event Description
It was reported that syringe 50ml ll tip 1ml leaked.The following information was provided by the initial reporter: 50cc syringe filled with propofol then want to fill the perfusion line but the liquid flows at the back of the stopper.
 
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Brand Name
SYRINGE 50ML LL TIP 1ML
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
MDR Report Key12515149
MDR Text Key272893116
Report Number1911916-2021-01014
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903096534
UDI-Public00382903096534
Combination Product (y/n)N
PMA/PMN Number
K110771
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 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309653
Device Lot Number1056652
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2021
Date Manufacturer Received09/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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