MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ ALLERGY SYRINGE; PISTON SYRINGE

Model Number	305536
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle detached from the bd¿ allergy syringe, and glue was found inside the cap.This occurred with 25 separate syringes.The following information was provided by the initial reporter: "needle was detached from syringe.Appears to be glued inside cap.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Correction: the following information has been updated: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 15-mar-2022.Investigation: h.6.Investigation summary: customer returned (1) loose 1/2ml allergy syringe.Customer states that that the needle was detached from syringe.The returned syringe was examined and exhibited the hub assembly separated from the barrel.Manufacturing (holdrege) will be notified of this issue.A review of the device history record was completed for batch #0323185.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Capa pr1630423 has been opened to address this issue.
Event or Problem Description
It was reported that the needle detached from the bd¿ allergy syringe, and glue was found inside the cap.This occurred with 25 separate syringes.The following information was provided by the initial reporter: "needle was detached from syringe.Appears to be glued inside cap.".

• Brand Name: BD¿ ALLERGY SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13595880
• Report Number: 1920898-2022-00125
• Device Sequence Number: 1930477
• Product Code: FMF
• UDI-Device Identifier: 30382903055365
• UDI-Public: 30382903055365
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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: 11/30/2025
• Device Model Number: 305536
• Device Catalogue Number: 305536
• Device Lot Number: 0323185
• 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: 11/13/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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