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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 30ML LL; SYRINGE, PISTON
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BECTON DICKINSON SYRINGE 30ML LL; SYRINGE, PISTON Back to Search Results
Catalog Number 301229
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2024
Event Type  malfunction  
Event Description
Short description: the plastic is defective on both the plunger and the syringe.Holes and cracks.When did the incident occur? during use.
 
Manufacturer Narrative
Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
 
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Brand Name
SYRINGE 30ML LL
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18874510
MDR Text Key337739992
Report Number3003152976-2024-00147
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903012299
UDI-Public(01)00382903012299
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number301229
Device Lot Number2311006
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/04/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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