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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE Back to Search Results
Model Number 300912
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0126665, medical device expiration date: 2025-04-30, device manufacture date: (b)(6) 2020. Medical device lot #: 0126661, medical device expiration date: 2025-04-30, device manufacture date: (b)(6) 2020. 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 0. 2 ml of medication remained in the bd luer-lok¿ tip syringe after the infusion when used with the b. Braun perfusor space pump. This occurred once each in lots 0126665 and 0126661. The following information was provided by the initial reporter: "0,2 ml of drug remains in syringe after infusion when used with b. Braun syringe pump the complaint is regarding remains of drug equivalent to about 0,2 ml after finalized infusion using b. Braun perfusor space pump. ".
 
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Brand NameBD LUER-LOK¿ TIP 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12312611
MDR Text Key266188824
Report Number1213809-2021-00561
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number300912
Device Catalogue Number300912
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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