MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL W/NDL 22X1-1/2 RB; PISTON SYRINGE

Model Number	309631
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the syringe 5ml ll w/ndl 22x1-1/2 rb leaked diluent while reconstituting the pfizer covid-19 vaccine.The following information was provided by the initial reporter: "few vials of pfizer covid-19 vaccines wasted due to faulty syringes.During reconstitution, the diluent leaked out of the syringe before it could be injected into the vaccine vial." bd supplied 309631 combo conventional - syringe 5ml needle 22g x 1.5" to barda as part of the u.S.Covid-19 vaccination campaign.The stated need was to supply these as part of reconstitution for vaccines.3 million units of 306931 were supplied in january and february.That product was then supplied to end-user vaccinator sites.
Event or Problem Description
It was reported that the syringe 5ml ll w/ndl 22x1-1/2 rb leaked diluent while reconstituting the pfizer covid-19 vaccine.The following information was provided by the initial reporter: "few vials of pfizer covid-19 vaccines wasted due to faulty syringes.During reconstitution, the diluent leaked out of the syringe before it could be injected into the vaccine vial.".¿ bd supplied 309631 combo conventional - syringe 5ml needle 22g x 1.5" to barda as part of the u.S.Covid-19 vaccination campaign.¿ the stated need was to supply these as part of reconstitution for vaccines.¿ (b)(4) units of 306931 were supplied in january and february.¿ that product was then supplied to end-user vaccinator sites.
Additional Manufacturer Narrative
H6: investigation summary.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: SYRINGE 5ML LL W/NDL 22X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11826263
• Report Number: 1213809-2021-00325
• Device Sequence Number: 3724868
• Product Code: FMF
• UDI-Device Identifier: 30382903096313
• UDI-Public: 30382903096313
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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
• Operator of Device: Other
• Device Expiration Date: 08/31/2025
• Device Model Number: 309631
• Device Catalogue Number: 309631
• Device Lot Number: 0247558
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1