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	Missing Information (4053)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
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 came unlabeled.No patient impact reported.The following information was provided by the initial reporter: we have been having problems with syringes.These came unlabeled.
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 came unlabeled.No patient impact reported.The following information was provided by the initial reporter: we have been having problems with syringes.These came unlabeled.
Additional Manufacturer Narrative
H6: investigation summary.Customer returned photos of a tray of syringes from lot # 1026233.Customer states that they came unlabeled.The photo was examined and exhibited a tray with a partially printed tray cover.The labeling issue will 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 able to duplicate or confirm the customer¿s indicated failure (labeling).A definite root-cause could not be determined.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as dir 10000690801.This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: allergy syringe.Device failure: labeling concerns.
Event or Problem Description
No additional information.

• 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: 15554029
• Report Number: 1920898-2022-00690
• Device Sequence Number: 2984409
• 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,Followup
• Report Date (Section B): 03/11/2025

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; Not provided
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/08/2022; 03/18/2025
• 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