MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ ALLERGY SYRINGE; PISTON SYRINGE

Model Number	305542
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd¿ allergy syringe boxes had the wrong printed information.The following information was provided by the initial reporter: it was reported that customer received boxes that are printed on the outside as treatment syringes have testing syringes inside.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
H6: investigation summary: customer returned a photo of 1/2cc and 1cc bd allergy syringes in trays.Customer states that received boxes that are printed on the outside as treatment syringes have testing syringes inside.The photo was examined and the trays exhibit the correct cover with the correct product information on them.No defects were observed.Due to the batch being unknown, no dhr review can be completed.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.
Event or Problem Description
It was reported that the bd¿ allergy syringe boxes had the wrong printed information.The following information was provided by the initial reporter: it was reported that customer received boxes that are printed on the outside as treatment syringes have testing syringes inside.

• Brand Name: BD¿ ALLERGY SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15263065
• Report Number: 1213809-2022-00513
• Device Sequence Number: 17645749
• Product Code: FMF
• UDI-Device Identifier: 30382903055426
• UDI-Public: 30382903055426
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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 Model Number: 305542
• Device Catalogue Number: 305542
• Device Lot Number: UNKNOWN
• 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: 07/25/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 08/20/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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