MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 30GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928853
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown the customer's address is unknown.New jersey (nj), usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that a syringe 1.0ml 30ga 8mm 10bag 500 pl/wg had missing label information before use.The following was reported by the initial reporter: "it was reported that expiration date is missing from shelf carton.Pr 2271243 records issue if missing expiration date for cat 928853.Pr 2276138 records issue if missing expiration date for cat 928854.Verbatim: walgreen's pharmacist stated he had 3 boxes of insulin syringes without expiration dates.Advised that the product boxes could be expired.".
Event or Problem Description
It was reported that a syringe 1.0ml 30ga 8mm 10bag 500 pl/wg had missing label information before use.The following was reported by the initial reporter: "it was reported that expiration date is missing from shelf carton.(b)(4) records issue if missing expiration date for cat 928853.(b)(4) records issue if missing expiration date for cat 928854.Verbatim: walgreen's pharmacist stated he had 3 boxes of insulin syringes without expiration dates.Advised that the product boxes could be expired.".
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# 5152535.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.This batch was manufactured before expiration dates were printed on packaging.

• Brand Name: SYRINGE 1.0ML 30GA 8MM 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: 11248512
• Report Number: 1920898-2021-00129
• Device Sequence Number: 3111254
• Product Code: FMF
• UDI-Device Identifier: 00311917025292
• UDI-Public: 00311917025292
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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: Other
• Device Model Number: 928853
• Device Catalogue Number: 928853
• Device Lot Number: 5152538
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1