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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 Break (1069)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)
Event Date 04/26/2021
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 needle broke.The following information was provided by the initial reporter: needles are consistently bent when taken out of packaging, approx 8 out of 10 times.We find that the needles appear blunt, this is noticeable when puncturing the vial and there has been a big increase in patients complaining of pain.When using our previous stock generally patients would report that they didn't or barely felt any pain on receiving the vaccine.Staff suggest at least 50% increase in complaints of pain.Staff say the needle is often blunt and it is difficult to puncture the skin.Today we had a needle that came out of the packaging with several mm missing and no bevel tip.Both before and after - some needles are clearly blunt and others are not able to pierce the skin, therefore requiring a number of attempts.Vial drawn up as required depending on number of patients that are needing to vaccinate.Usually 2 in advance.Approximately how many / what proportion of the cns experienced this issue? - approx 8 out of 10.If yes, is the needle shield replaced after vaccine is drawn up, prior to administration? y/n - yes.Any harm to the patient? yes - multiple reports of pain, bleeding which hasnt been reported before.Was there any exposure to blood/bodily fluid? y/n - yes.
 
Manufacturer Narrative
H6: investigation summary: a device history record review was completed for provided lot number 2006405.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.The picture showed the syringe outside of the product packaging with a broken cannula.As samples were unavailable for return, twenty retained samples of the same lot number were obtained from the manufacturing facility for review.The retained samples were examined and the cannulas were found to be well formed with no signs of blunt point, breakage, or damage.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this incident.Considering that the needle was not broken before use, we cannot discard the handling of the product as having a potential impact on the issue reported.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.H3 other text : see h10.
 
Event Description
It was reported that syringe flu plus 0.25-1ml var dose 23x1 needle broke.The following information was provided by the initial reporter: needles are consistently bent when taken out of packaging, approx 8 out of 10 times.We find that the needles appear blunt, this is noticeable when puncturing the vial and there has been a big increase in patients complaining of pain.When using our previous stock generally patients would report that they didn't or barely felt any pain on receiving the vaccine.Staff suggest at least 50% increase in complaints of pain.Staff say the needle is often blunt and it is difficult to puncture the skin.Today we had a needle that came out of the packaging with several mm missing and no bevel tip.Both before and after - some needles are clearly blunt and others are not able to pierce the skin, therefore requiring a number of attempts.Vial drawn up as required depending on number of patients that are needing to vaccinate.Usually 2 in advance.Approximately how many / what proportion of the cns experienced this issue? - approx 8 out of 10.If yes, is the needle shield replaced after vaccine is drawn up, prior to administration? y/n - yes.Any harm to the patient? yes - multiple reports of pain, bleeding which hasnt been reported before.Was there any exposure to blood/bodily fluid? y/n - yes.
 
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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 Key11891445
MDR Text Key253492390
Report Number3002682307-2021-00212
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 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305832
Device Lot Number2006405
Was Device Available for Evaluation? No
Date Manufacturer Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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