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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE 1ML 27GA 1/2IN P

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BECTON DICKINSON DE MEXICO SYRINGE 1ML 27GA 1/2IN P Back to Search Results
Catalog Number 326716
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2021
Event Type  malfunction  
Manufacturer Narrative
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 the syringe 1ml 27ga 1/2in p experienced missing label information. The following information was provided by the initial reporter: 1 shipping carton has been rejected because its label is damaged, inside the protection.
 
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Brand NameSYRINGE 1ML 27GA 1/2IN P
Type of DeviceSYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12170671
MDR Text Key262177791
Report Number9614033-2021-00079
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 10/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number326716
Device Lot Number1071209
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2021
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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