MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1; PISTON SYRINGE

Catalog Number 305832

Device Problem Leak/Splash (1354)

Patient Problem Bruise/Contusion (1754)

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2006425.Medical device expiration date: 2025-05-31.Device manufacture date: 2020-06-09.Medical device lot #: 2006423.Medical device expiration date: 2025-05-31.Device manufacture date: 2020-06-09.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 were bent and leaked.The following information was provided by the initial reporter: we are only able to draw up 8 dose most times, from the 8 dose vials, when using the other syringes we are able to draw up a second dose.This means we are not utilizing all the vaccine.It also leaks out of the vial again losing vaccine from vial.On some syringes needles appear to be bent.It's hard to put the correct dose in syringes at times, bung not straight and the bung is thick.This can lead to miss dosing and its time consuming.It has also been reported to me that citizen flinch more during vaccination and the incidence of post bleeding after vaccination seem to be higher.I have also noticed that bubbles seem to appear in the syringe after the vaccine has been drawn up.Follow up received on 1st april 2021, reporter answering some of the questions we have raised: are you able to clarify the reason you are drawing up fewer doses? it seems to be from the vaccine leaking and small bubbles appearing after the dose has been drawn up this has happened with a few users so doesn¿t appear to be user error.Are the needles bent prior to putting them through the bung, or is the bending happening when pushing through the bung? some needles are bent prior to drawing up others angle when putting in to vial even if you go in at a right angle.

Manufacturer Narrative

Investigation: a device history record review was completed for provided lot numbers 2006425 and 2006423.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.As samples were unavailable for return, twenty retained samples for each lot number were obtained from the manufacturing facility.The retained samples were visually examined and the cannulas were found to be well-formed with no signs of blunt points.The syringes were used to draw up liquid and no signs of leakage were observed.No defects were identified through the evaluation of the retained samples.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this incident.

Event Description

It was reported that syringe flu plus 0.25-1ml var dose 23x1 were bent and leaked.The following information was provided by the initial reporter: we are only able to draw up 8 dose most times, from the 8 dose vials, when using the other syringes we are able to draw up a second dose.This means we are not utilizing all the vaccine.It also leaks out of the vial again losing vaccine from vial.On some syringes needles appear to be bent.It's hard to put the correct dose in syringes at times, bung not straight and the bung is thick.This can lead to miss dosing and its time consuming.It has also been reported to me that citizen flinch more during vaccination and the incidence of post bleeding after vaccination seem to be higher.I have also noticed that bubbles seem to appear in the syringe after the vaccine has been drawn up.Follow up received on 1st april 2021, reporter answering some of the questions we have raised: are you able to clarify the reason you are drawing up fewer doses? it seems to be from the vaccine leaking and small bubbles appearing after the dose has been drawn up this has happened with a few users so doesn¿t appear to be user error.Are the needles bent prior to putting them through the bung, or is the bending happening when pushing through the bung? some needles are bent prior to drawing up others angle when putting in to vial even if you go in at a right angle.

• 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 Key: 11749888
• MDR Text Key: 273200468
• Report Number: 3002682307-2021-00165
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305832
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1