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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY PISTON SYRINGE Back to Search Results
Catalog Number 301029
Device Problems Volume Accuracy Problem (1675); Defective Device (2588); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Lot number was not reported; however, potential lot numbers were provided. The information for those numbers is as follows: medical device lot #: 1111285. Medical device expiration date: mar 31 2026. Device manufacture date: apr 30 2021. Medical device lot #: 1152292. Medical device expiration date: may 31 2026. Device manufacture date: june 30 2021. Medical device lot #: 1111296. Medical device expiration date: apr 30 2026. Device manufacture date: may 27 2021. Medical device lot #: 1239987. Medical device expiration date: aug 31 2026. Device manufacture date: sept 9 2021. Medical device lot #: 1270083. Medical device expiration date: aug 31 2026. Device manufacture date: oct 1 2021. A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported while using bd luer-lok¿ 10 ml bulk pack luer lock tip without safety three syringes were found to be deformed and broken, one syringe had foreign matter contaminating the fluid pathway, and one syringe had unclear scale markings. The following information was provided by the initial reporter: material 301029 batch unknown ( possible lot 1111285, 1152292, 1111296, 1239987, 1270083). 1 syringe bad print, 1 syringe ink contamination, 3 syringes deformed and broken.
 
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Brand NameBD LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY
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 Key13559019
MDR Text Key286020388
Report Number1213809-2022-00085
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 03/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number301029
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2022
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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