MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE SHIELDING HYPODERMIC NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305924
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: piston syringe.Medical device type: fmf.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980987 (syringe), pma / 510(k)#: k951254 (needle).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 6 bd safetyglide¿ shielding hypodermic needles had visible cracks on their syringes that leaked vaccine medicine.The following information was provided by the initial reporter: "diluent was drawn up and being injected into pfizer covid vaccine vial.Writer noted drops of fluid appearing on outdid of syringe from vertical crack visible/palpable on syringe.Consequently, six (6) doses of vaccine was discarded as unsure of exact amount of diluent that had been injected into vial.".
Additional Manufacturer Narrative
H6: investigation summary: one loose 3ml syringe with an opened and empty blister pack from batch 6305556 (p/n 305924) were received and evaluated.It was observed that there was a lengthwise crack inside the grad lines extending from the 1ml marking to the 2ml marking.Potential root cause for the cracked barrel defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.Batch 6305556 is considered in compliance with our product specification requirements.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.H3 other text : see h10.
Event or Problem Description
It was reported that 6 bd safetyglide¿ shielding hypodermic needles had visible cracks on their syringes that leaked vaccine medicine.The following information was provided by the initial reporter: "diluent was drawn up and being injected into pfizer covid vaccine vial.Writer noted drops of fluid appearing on outdid of syringe from vertical crack visible/palpable on syringe.Consequently, 6 doses of vaccine was discarded as unsure of exact amount of diluent that had been injected into vial.".

• Brand Name: BD SAFETYGLIDE SHIELDING HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11624918
• Report Number: 1213809-2021-00211
• Device Sequence Number: 3919996
• Product Code: FMI
• UDI-Device Identifier: 30382903059240
• UDI-Public: 30382903059240
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: SEE H.10.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2021
• Device Model Number: 305924
• Device Catalogue Number: 305924
• Device Lot Number: 6305556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1