MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 21X1-1/2 RB; PISTON SYRINGE

Model Number	309577
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2020
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.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 21x1-1/2 rb was missing label information.This was discovered before use.The following information was provided by the initial reporter: material no.309577 batch no.2150297.It was reported that expiration date is missing from shelf carton.
Additional Manufacturer Narrative
Investigation summary no photos or samples were received for evaluation.The batch numbers provided: 4154804, 3298116, 0054508, 2150297, and 3212011 were all manufactured prior to the udi requirements that mandated marking individual packaging with expiration date.These batches were all manufactured correctly per product design at that time.The most recent batch, #4154804, was expired as of 31 may 2019.The reported defect was not identified based on the product information provided and no corrective actions are necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl 21x1-1/2 rb was missing label information.This was discovered before use.The following information was provided by the initial reporter: material no.309577 batch no.2150297.It was reported that expiration date is missing from shelf carton.

• Brand Name: SYRINGE 3ML LL W/NDL 21X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10112386
• Report Number: 1213809-2020-00359
• Device Sequence Number: 2405525
• Product Code: FMF
• UDI-Device Identifier: 30382903095774
• UDI-Public: 30382903095774
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/04/2020

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: 309577
• Device Catalogue Number: 309577
• Device Lot Number: 2150297
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/04/2020
• 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