MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL W/NDL 20X1-1/2 RB; PISTON SYRINGE

Model Number	309645
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2020
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 is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 10 syringes 10ml ll w/ndl 20x1-1/2 rb experienced no label or missing label information which was noted prior to use.The following information was provided by the initial reporter: material no.: 309645, batch no.: 5246743.Syringes missing expiration date and lot numbers missing numbers/ hard to read.
Additional Manufacturer Narrative
H.6.Investigation summary : two photos of blister packs (p/n 309645) were received and evaluated.One photo displayed a fully sealed blister pack from batch 5246743.One photo displayed three blister packs with one from batch 7060550, one from batch 9143661, and one unknown.The different graphics and/or information between the packages shown in the photos is due to changes in fda requirements.The first change occurred in 2016, in which the udi must include the expiration date as shown on the package from batch 7060550.The second change occurred in 2018, in which the udi must include the product information as a 2d barcode as shown on package from batch 9143661.All the packages shown were in compliance with the labelling requirements at the time of manufacture.Additionally, the products have a 5-year expiration window.Batch 5246743 expires 8/31/2020.The reported defect was not identified in the photos received.A device history review was conducted for lot number 5246743.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.H3 other text : see section h.10.
Event or Problem Description
It was reported that 10 syringes 10ml ll w/ndl 20x1-1/2 rb experienced no label or missing label information which was noted prior to use.The following information was provided by the initial reporter: material no.: 309645 batch no.: 5246743.Syringes missing expiration date and lot numbers missing numbers/ hard to read.

• Brand Name: SYRINGE 10ML LL W/NDL 20X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9868325
• Report Number: 1213809-2020-00197
• Device Sequence Number: 16793457
• Product Code: FMF
• UDI-Device Identifier: 30382903096450
• UDI-Public: 30382903096450
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/31/2020
• Device Model Number: 309645
• Device Catalogue Number: 309645
• Device Lot Number: 5246743
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 03/31/2020
• 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