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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGE 3ML LL 22GA 1-1/4IN MX BUN; PISTON SYRINGE
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BECTON DICKINSON DE MEXICO BD SYRINGE 3ML LL 22GA 1-1/4IN MX BUN; PISTON SYRINGE Back to Search Results
Catalog Number 302541
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2022
Event Type  malfunction  
Event Description
It was reported when using the bd syringe 3ml ll 22ga 1-1/4in mx bun, the user identified a clogged needle.The following information was provided by the initial reporter.The customer stated: a syringe with a clogged needle.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval: yes.D.9.Returned to manufacturer on: 05-aug-2022.H.6.Investigation summary: two samples and three photos received for investigation.Upon visual inspection of the samples, no defects related to molding or foreign matter is observed.Functional test was completed, liquid did not flow through the cannula, clogged needle is confirmed.Possible root cause for clogged needle is associated with visions system and epoxy dispenser.Action was taken, for clogged needle ensuring the camera is permanently attached to the equipment.Capa pr# 1381222 h3 other text : see h.10.
 
Event Description
It was reported when using the bd syringe 3ml ll 22ga 1-1/4in mx bun, the user identified a clogged needle.The following information was provided by the initial reporter.The customer stated: a syringe with a clogged needle.
 
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Brand Name
BD SYRINGE 3ML LL 22GA 1-1/4IN MX BUN
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer (Section G)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13624775
MDR Text Key286958576
Report Number9614033-2022-00011
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
NA
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 08/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302541
Device Lot Number0332987
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2022
Initial Date FDA Received02/28/2022
Supplement Dates Manufacturer Received08/08/2022
Supplement Dates FDA Received08/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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