MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 27 G X 3/8 IN., 0.5 ML; PISTON SYRINGE

Catalog Number	305536
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd¿ allergy syringe with permanently attached needle 27 g x 3/8 in., 0.5 ml had rust on it.No patient impact reported.The following information was provided by the initial reporter: my nurses said a needle had visible rust on it.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.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 bd¿ allergy syringe with permanently attached needle 27 g x 3/8 in., 0.5 ml had rust on it.No patient impact reported.The following information was provided by the initial reporter: my nurses said a needle had visible rust on it.
Additional Manufacturer Narrative
H6: investigation summary: customer returned photos of a tray of syringes from lot # 1026233.Customer states a needle had visible rust on it.No images of the syringes were returned so the foreign matter issue cannot be confirmed.A review of the device history record was completed for batch #1026233.All inspections were performed per the applicable operations qc specifications.Embecta was not able to duplicate or confirm the customer¿s indicated failure (fm).A definite root-cause could not be determined.

• Brand Name: BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 27 G X 3/8 IN., 0.5 ML
• 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: 15554302
• Report Number: 1920898-2022-00689
• Device Sequence Number: 19579312
• Product Code: FMF
• UDI-Device Identifier: 00382903055364
• UDI-Public: 00382903055364
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 01/31/2026
• Device Catalogue Number: 305536
• Device Lot Number: 1026233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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