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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 Problems Leak/Splash (1354); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: (b)(6).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 flu plus 0.25-1ml var dose 23x1 experienced a bent tip of the syringe and the packaging was breached by the needle.The following information was provided by the initial reporter: see below needle we have found.
 
Event Description
It was reported that the syringe flu plus 0.25-1ml var dose 23x1 experienced a bent tip of the syringe and the packaging was breached by the needle.The following information was provided by the initial reporter: see below needle we have found.
 
Manufacturer Narrative
H.6.Investigation: a device history record review was completed for provided bd material 305832 and lot number 2012416.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.To aid in the investigation of this issue, a picture sample was returned for evaluation by our quality engineer team.Through examination of the picture, a cannulated barrel was observed without a plunger or shield component, confirming a product defect.It has been determined that this incident resulted from a faulty syringe going through the packaging machine; however, the exact cause for the introduction of this faulty syringe could not be determined.H3 other text : see h.10.
 
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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
MDR Report Key12081491
MDR Text Key259156972
Report Number3002682307-2021-00288
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K091377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305832
Device Lot Number2012416
Was Device Available for Evaluation? No
Date Manufacturer Received09/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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