MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 8MM 10BAG 500 PL/WG; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	928855
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.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 syringe 0.3ml 30ga 8mm 10bag 500 pl/wg was missing label information.The following information was provided by the initial reporter: material no: 928855, batch no: 1116423.It was reported that the bag of syringes did not have a date on the bag.Verbatim: consumer reported found 10 pack of (b)(4) syringes.Was asking if they expire - did not see a date on bag.Obtained the lot # and determined this product was expired.She did not use this item in years.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Due to this batch being made in 2011 and files are retained for 7 years, no dhr is able to be completed.Bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
Event or Problem Description
It was reported that syringe 0.3ml 30ga 8mm 10bag 500 pl/wg was missing label information.The following information was provided by the initial reporter: material no: 928855 batch, no: 1116423.It was reported that the bag of syringes did not have a date on the bag.Verbatim: consumer reported found 10 pack of walgreen syringes.Was asking if they expire - did not see a date on bag.Obtained the lot # and determined this product was expired.She did not use this item in years.

• Brand Name: SYRINGE 0.3ML 30GA 8MM 10BAG 500 PL/WG
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10889709
• Report Number: 1920898-2020-01610
• Device Sequence Number: 16501187
• Product Code: FMI
• UDI-Device Identifier: 00311917025278
• UDI-Public: 00311917025278
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K955235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 928855
• Device Catalogue Number: 928855
• Device Lot Number: 1116423
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1