MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928852
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
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.".
Event or Problem Description
It was reported that a box of syringe 0.3ml 29ga 1/2in 10bag 500 pl/wg had missing label information before use.The following was reported by the initial reporter: "it was reported that the expiration dates were not on the box.Verbatim: pharmacy reported found full box of (b)(6) insulin syringe 30g, 0.3ml 8mm with lot # 6347590, lot # 6347590, catalog# 928855, date of event: (b)(6) 2021, sample no.Pharmacy reported found full box of (b)(6) insulin syringe without exp dates".
Additional Manufacturer Narrative
H.6.Investigation: 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 # 5229810 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.This was manufactured before expiration dates were printed on packaging.H3 other text : see h.10.
Event or Problem Description
It was reported that a box of syringe 0.3ml 29ga 1/2in 10bag 500 pl/wg had missing label information before use.The following was reported by the initial reporter: "it was reported that the expiration dates were not on the box.Verbatim: pharmacy reported found full box of walgreens insulin syringe 30g, 0.3ml 8mm with lot # 6347590.Lot # 6347590.Catalog# 928855.Date of event (b)(6) 2021.Sample no.Pharmacy reported found full box of walgreens insulin syringe without exp dates.".

• Brand Name: SYRINGE 0.3ML 29GA 1/2IN 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11692925
• Report Number: 1920898-2021-00430
• Device Sequence Number: 3511453
• Product Code: FMF
• UDI-Device Identifier: 00311917014920
• UDI-Public: 00311917014920
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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 Model Number: 928852
• Device Catalogue Number: 928852
• Device Lot Number: 5229810
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1