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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE NON STERILE 50ML LL

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BECTON DICKINSON, S.A. SYRINGE NON STERILE 50ML LL Back to Search Results
Catalog Number 300223
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used. Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 2103502, medical device expiration date: 2026-02-28, device manufacture date: 2021-03-23. Medical device lot #: 2104120, medical device expiration date: 2026-03-31, device manufacture date: 2021-04-26. Investigation summary: samples and photos received for investigation. Upon observation, all syringes received present defects in the luer lock and tip pf the syringe. One syringe has the luer lock detached. Five syringes present the tip completely detached, and two devices have the thread damaged. The eight syringes sent by customer came without lot number identification, so we cannot associate to each device one of the two lot numbers given. A device history review was performed for reported lot 2103502 and 2104120, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue. Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures. Possible root cause can be related with the damaged pins in the mold where the parts were manufactured. We appreciate you taking the time to bring this observation to our attention. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. No corrective action is required at this time.
 
Event Description
It was reported that syringe non sterile 50ml ll was damaged. This occurred on 7200 occasions. The following information was provided by the initial reporter: according to our analysis, it is an injection molding defect on the luer cone. To us, it looks like the cone is injected twice.
 
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Brand NameSYRINGE NON STERILE 50ML LL
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12576489
MDR Text Key274782329
Report Number3003152976-2021-00659
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeGM
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 09/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300223
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
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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