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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1; PISTON SYRINGE
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BECTON DICKINSON, S.A. SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1; PISTON SYRINGE Back to Search Results
Catalog Number 305832
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that syringe flu plus 0.25-1ml var dose 23x1 had scale marking issues.The following information was provided by the initial reporter: markings on the syringe set an angle giving the impression that they are not straight.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 2006428.D.4.Medical device expiration date: 5/31/2025.H.4.Device manufacture date: 6/17/2020.D.4.Medical device lot #: 2012415.D.4.Medical device expiration date: 11/30/2025.H.4.Device manufacture date: 12/14/2020.D.4.Medical device lot #: 2006404.D.4.Medical device expiration date: 5/31/2025/ h.4.Device manufacture date: 6/2/2020.D.4.Medical device lot #: 2006427.D.4.Medical device expiration date: 5/31/2025.H.4.Device manufacture date: 6/17/2020.D.4.Medical device lot #: 2006429.D.4.Medical device expiration date: 5/31/2025.H.4.Device manufacture date: 6/17/2020.H.6.Investigation: a device history record review was completed for provided lot numbers 2006428, 2012415, 2006404, 2006427, and 2006429.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defects and all quality tests were found to be within specification.To aid in the investigation of this incident, thirty-four samples with open blister packages were returned for evaluation by our quality engineer team.The syringes were examined and six needles were found bent outside of specifications, three of the bent needles were found to be slightly blunt, one syringe presented a scale marking issue where the scale was legible but slightly blurred, and none of the syringes showed signs of air bubbles.Regarding the scale marking issue, an unexpected malfunction with the roller system which transfers ink to the syringe must have occurred, causing the scale to print slightly blurred.As our quality team was unable to reproduce the reported defect of air bubbles, a cause could not be determined for this defect.
 
Event Description
It was reported that syringe flu plus 0.25-1ml var dose 23x1 had scale marking issues.The following information was provided by the initial reporter: markings on the syringe set an angle giving the impression that they are not straight.
 
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Brand Name
SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1
Type of Device
PISTON 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 Key12298183
MDR Text Key265805896
Report Number3002682307-2021-00396
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K091377
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
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 Number305832
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/12/2021
Initial Date FDA Received08/09/2021
Supplement Dates Manufacturer Received10/27/2021
Supplement Dates FDA Received11/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2020
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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