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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 5ML LS 22X1-1/4 DN EMERALD PISTON SYRINGE

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BECTON DICKINSON, S.A. SYRINGE 5ML LS 22X1-1/4 DN EMERALD PISTON SYRINGE Back to Search Results
Catalog Number 30774319
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: a device history record review was completed for provided lot number 1906177. The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification. As samples were unavailable for this incident, a thorough sample evaluation could not be performed. Based on the provided feedback, it has been determined that this issue most likely resulted from human error during the manual labeling process of the extra label for the emerald china syringes. This extra label is placed on the box manually by the operator. Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence. Further action has not been determined necessary at this time. Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
 
Event Description
It was reported that the box of 2000 syringes 5ml ls 22x1-1/4 dn emerald had no label on it. The following information was provided by the initial reporter, translated from (b)(6) to english: "no label for the whole box".
 
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Brand NameSYRINGE 5ML LS 22X1-1/4 DN EMERALD
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP 22520
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP 22520
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12418281
MDR Text Key269802096
Report Number3002682307-2021-00459
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number30774319
Device Lot Number1906177
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2019
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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