MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 18X1-1/2 RB; PISTON SYRINGE

Catalog Number	309580
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 syringe 3ml ll w/ndl 18x1-1/2 rb was missing the expiration date.The following information was provided by the initial reporter: missing expiration date.Verbatim: pharmacy reported found opened boxes of product that appeared to be expired.After review of lot #s and item #s they are expired.
Additional Manufacturer Narrative
Investigation summary: the dhr was not reviewed because the product was manufactured in 2015 and expired in 2020.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl 18x1-1/2 rb was missing the expiration date.The following information was provided by the initial reporter: missing expiration date.Verbatim: pharmacy reported found opened boxes of product that appeared to be expired.After review of lot #s and item #s they are expired.

• Brand Name: SYRINGE 3ML LL W/NDL 18X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11931451
• Report Number: 1213809-2021-00393
• Device Sequence Number: 4395921
• Product Code: FMF
• UDI-Device Identifier: 00382903095803
• UDI-Public: 00382903095803
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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 Expiration Date: 08/31/2020
• Device Catalogue Number: 309580
• Device Lot Number: 5246886
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1