MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH BD PLASTIPAK¿ NEEDLE; PISTON SYRINGE

Catalog Number	309582
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1 bd luer-lok¿ syringe with bd plastipak¿ needle each from lots 0351036 and 0351028 had issues with the needle separating from the hub and leaking out the covid vaccine diluent.The following information was provided by the initial reporter: "twice we have had the needles pop off the syringe while instilling the diluent into the covid vial, causing the diluent to squirt out onto the counter.We have had to waste two vials of vaccine because we did not know how much diluent was injected into the covid vial and how much squirted out when the needle popped off the syringe.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0351036.Medical device expiration date: 30-nov-2025.Device manufacture date: 16-dec-2020.Medical device lot #: 0351028.Medical device expiration date: 30-nov-2025.Device manufacture date: 16-dec-2020.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 1 bd luer-lok¿ syringe with bd plastipak¿ needle each from lots 0351036 and 0351028 had issues with the needle separating from the hub and leaking out the covid vaccine diluent.The following information was provided by the initial reporter: "twice we have had the needles pop off the syringe while instilling the diluent into the covid vial, causing the diluent to squirt out onto the counter.We have had to waste two vials of vaccine because we did not know how much diluent was injected into the covid vial and how much squirted out when the needle popped off the syringe.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 23-mar-2023 h6: investigation summary three samples were provided to our quality team for investigation.The reported issue was not confirmed upon inspection of the samples.None of the samples showed any signs of the reported defect.Since the reported defect was not confirmed a manufacturing root cause could not be determined.A device history record review was completed for provided lot number 0351028, 0351034 and 0351036.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.H3 other text : see h10.
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 numbers that could have contributed to the reported defect.
Event or Problem Description
It was reported that 1 bd luer-lok¿ syringe with bd plastipak¿ needle each from lots 0351036 and 0351028 had issues with the needle separating from the hub and leaking out the covid vaccine diluent.The following information was provided by the initial reporter: "twice we have had the needles pop off the syringe while instilling the diluent into the covid vial, causing the diluent to squirt out onto the counter.We have had to waste two vials of vaccine because we did not know how much diluent was injected into the covid vial and how much squirted out when the needle popped off the syringe.".

• Brand Name: BD LUER-LOK¿ SYRINGE WITH BD PLASTIPAK¿ NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16483791
• Report Number: 1213809-2023-00149
• Device Sequence Number: 17832331
• Product Code: FMF
• UDI-Device Identifier: 00382903095827
• UDI-Public: 00382903095827
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2023

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 Catalogue Number: 309582
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 04/01/2023; 04/17/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/06/2023; 04/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown