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

Model Number	305540
Medical Device Problem Codes	Leak/Splash (1354); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd allergy syringe tray with bd precisionglide¿ permanently attached needle had a loose plunger that caused medication to leak out.The following information was provided by the initial reporter: "consumer reported loose plungers that do not create a seal and allow medication to leak out of syringe barrel.Consumer stated she has been using this item for over 10 years and never had a problem previously.Consumer stated she uses syringes to inject vitamin b12.Consumer stated she has 3 allergy syringe trays all with the same lot # but has only opened & experienced problems with one tray.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer 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 tray with bd precisionglide¿ permanently attached needle had a loose plunger that caused medication to leak out.The following information was provided by the initial reporter: "consumer reported loose plungers that do not create a seal and allow medication to leak out of syringe barrel.Consumer stated she has been using this item for over 10 years and never had a problem previously.Consumer stated she uses syringes to inject vitamin b12.Consumer stated she has 3 allergy syringe trays all with the same lot # but has only opened & experienced probelms with one tray.".
Additional Manufacturer Narrative
H6: investigation summary: since no samples (including photos) were returned for the reported issue of ¿"needle point missing¿ with lot number 9345898 regarding item # 305540 the complaint could not be confirmed, and the root cause is undetermined.A review of the device history record was completed for batch # 9345898.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.As no samples and/or photo(s) were received the investigation concluded that bd was not able to duplicate or confirm the indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.

• Brand Name: BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE¿ 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: 13391849
• Report Number: 1920898-2022-00047
• Device Sequence Number: 4252684
• Product Code: FMF
• UDI-Device Identifier: 30382903055402
• UDI-Public: 30382903055402
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 02/10/2022

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: Lay User/Patient
• Device Expiration Date: 12/31/2024
• Device Model Number: 305540
• Device Catalogue Number: 305540
• Device Lot Number: 9345898
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2019
• 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