MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 23X1 RB; PISTON SYRINGE

Model Number	309571
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.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 the box of syringes 3ml ll w/ndl 23x1 rb had no expiration date on the label.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter, "i have 6 boxes of syringes (100 count per box) that do not have an expiration date on the box and packaging.".
Event or Problem Description
It was reported that the box of syringes 3ml ll w/ndl 23x1 rb had no expiration date on the label.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "i have 6 boxes of syringes (100 count per box) that do not have an expiration date on the box and packaging.".
Additional Manufacturer Narrative
H.6.Investigation: two photos displaying a 100-count shelf carton and blister pack from batch 1053817 (p/n 309571) were received and evaluated.No defects were observed.The dhr for the product in this complaint is not available for review as records are only maintained for seven years.Based on the information on the label 1053817, the product was manufactured in 2010.This batch was manufactured prior to the unique device identification requirements that mandated marking individual packaging with expiration date.Batch 1053817 was manufactured correctly per product design at that time.Please note batches 1053817 was expired as of 2015 and bd does not make claims about the performance or efficacy of expired products.

• Brand Name: SYRINGE 3ML LL W/NDL 23X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10880909
• Report Number: 1213809-2020-00822
• Device Sequence Number: 2863043
• Product Code: FMF
• UDI-Device Identifier: 30382903095712
• UDI-Public: 30382903095712
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: Other
• Device Model Number: 309571
• Device Catalogue Number: 309571
• Device Lot Number: 1053817
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/21/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1