MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE; PISTON SYRINGE

Catalog Number	305500
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd allergy syringe with permanently attached needle the plunger movement was difficult.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported plunger would not move when trying to take her injection.Date of event: (b)(6)2022.Samples: yes cl.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: since no samples (including photos) were returned for the syringe allergy 1ml w/ndl 28x1/2 rb, product code#305500, from lot#9287325, with the reported issue of ¿plunger movement difficult¿, the complaint could not be confirmed, and the root cause is undetermined.A review of the device history record was completed for batch #9287325.All inspections were performed per the applicable operations qc specifications.
Event or Problem Description
It was reported while using bd allergy syringe with permanently attached needle the plunger movement was difficult.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported plunger would not move when trying to take her injection.Date of event: 2022-09-16, 2022-09-08, 2022-09-05.Samples: yes cl.
Event or Problem Description
It was reported while using bd allergy syringe with permanently attached needle the plunger movement was difficult.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported plunger would not move when trying to take her injection.Date of event: 2022-09-16, 2022-09-08, 2022-09-05.Samples: yes (b)(6).
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, h6: investigation summary customer returned (23) 1ml bd syringes from lot# 9287325.The customer reported that the plunger would not move when trying to take injection.The samples were examined, then tested for plunger rod movement: all 23 syringes featured plunger rods that were able to move through the respective barrel properly.No evidence of manufacturing defect was observed.The alleged defect could not be confirmed based on the samples provided for investigation.A review of the device history record was completed for batch #9287325.All inspections were performed per the applicable operations qc specifications.Embecta was not able to duplicate or confirm the customer¿s indicated failure root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: BD ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE
• 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: 15556798
• Report Number: 1920898-2022-00697
• Device Sequence Number: 20603756
• Product Code: FMF
• UDI-Device Identifier: 00382903055005
• UDI-Public: 00382903055005
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2022

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: Lay User/Patient
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: 305500
• Device Lot Number: 9287325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 10/27/2022; 12/20/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/10/2022; 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2019
• 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