MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE WALGREENS SUPER THIN II SYRINGES SHORT NEEDLE; PISTON SYRINGE

Model Number	928854
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event is unknown.Awareness date has been used for this field.Address information was not able to be obtained.Therefore; nj was used as a place holder.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using walgreens super thin ii syringes short needle the expiration date was missing.There was no report of patient impact.The following information was provided by the initial reporter: pharmacist called to inquire about expiration date on syringes.There is no expiration date on the box.
Additional Manufacturer Narrative
H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 7352875.All inspections and challenges were performed per the applicable operations qc specification.H3 other text : see h10.
Event or Problem Description
It was reported while using walgreens super thin ii syringes short needle the expiration date was missing.There was no report of patient impact.The following information was provided by the initial reporter: pharmacist called to inquire about expiration date on syringes.There is no expiration date on the box.

• Brand Name: WALGREENS SUPER THIN II SYRINGES SHORT 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: 15983001
• Report Number: 1920898-2022-00876
• Device Sequence Number: 5896912
• Product Code: FMF
• UDI-Device Identifier: 00311917025285
• UDI-Public: (01)00311917025285
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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: Health Professional
• Device Expiration Date: 02/08/2023
• Device Model Number: 928854
• Device Catalogue Number: 928854
• Device Lot Number: 7352875
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2018
• 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