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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 301073
Device Problems Break (1069); Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1176912. Medical device expiration date: 2026-05-31. Device manufacture date: 2021-06-25. Medical device lot #: 1300340. Medical device expiration date: 2026-09-30. Device manufacture date: 2021-10-27. 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 1 bd luer-lok¿ syringe had illegible scale printing, and 2 syringes had broken barrels/flanges. The following information was provided by the initial reporter, translated from (b)(6): "1 syringe bad printing, 2 syringes broken parts".
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1176912. Medical device expiration date: 2026-05-31. Device manufacture date: 2021-06-25. Medical device lot #: 1300340. Medical device expiration date: 2026-09-30. Device manufacture date: 2021-10-27. 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 1 bd luer-lok¿ syringe had illegible scale printing, and 2 syringes had broken barrels/flanges. The following information was provided by the initial reporter, translated from (b)(6): "1 syringe bad printing, 2 syringes broken parts".
 
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Brand NameBD LUER-LOK¿ SYRINGE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13551168
MDR Text Key286020636
Report Number1213809-2022-00083
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number301073
Device Lot NumberSEE SECTION H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2022
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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