MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE SAFETYLOK 3ML LL W/NDL 25X5/8; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	309592
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/16/2020
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: na.The customer's address is unknown.Unknown, (b)(6) usa has been used as a default.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that there was no expiration date on the syringe safetylok 3ml ll w/ndl 25x5/8 before use.The following information was provided by the initial reporter: "consumer reported no exp date on box.Found within her storage was using for bd.She will be discarding these syringes.".
Event or Problem Description
It was reported that there was no expiration date on the syringe safetylok 3ml ll w/ndl 25x5/8 before use.The following information was provided by the initial reporter: "consumer reported no exp date on box.Found within her storage was using for bd.She will be discarding these syringes.".
Additional Manufacturer Narrative
H6.Investigation: no photos or samples were received for evaluation.Batch 2268134 is unavailable for review as records are only maintained for seven years.Batch #2268134 was manufactured in 2012 ¿ prior to the udi requirements that mandated marking individual packaging with expiration date.This batch was manufactured correctly per product design at that time.Please note batch #2268134 was expired as of 2017 and bd does not make claims about the performance or efficacy of expired products.Reported defect was not identified based on the product information provided and no corrective actions are necessary at this time.H3 other text : see h10.

• Brand Name: SYRINGE SAFETYLOK 3ML LL W/NDL 25X5/8
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10237795
• Report Number: 1213809-2020-00441
• Device Sequence Number: 2485520
• Product Code: FMI
• UDI-Device Identifier: 30382903095927
• UDI-Public: 30382903095927
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• Number of Events Summarized: 1
• Summary Report (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): 07/10/2020

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: 309592
• Device Catalogue Number: 309592
• Device Lot Number: 2268134
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other