MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE SAFETYLOK 10ML LL; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305559
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
Material no: 305559 batch no: 4294859.It was reported that before use of the syringe safetylok 10ml ll the expiration date is listed on the shelf pack but not on the individual product blister packs.The shelf pack has the expiration date of the syringes listed, but there is no expiration date on the individual packages.This can lead to use of expired product once the syringes are removed from the shelf pack.
Additional Manufacturer Narrative
H.6.Investigation summary: a re-sealed shelf carton was received, containing approximately 50 safety-lok 10ml packages, confirmed to be from batch #4294859 (p/n 305559).One package was received opened.The label on the shelf carton stated expiration date ¿2019-10,¿ indicating that the product had expired by the time of this evaluation.There was no expiration date printed on individual product packaging.No packaging defects were observed.Batch #4294859 was manufactured in 2014 ¿ prior to the udi requirements that mandated marking individual packaging with expiration date.This batch was manufactured correctly per product design at that time.The reported defect was not identified in the samples received.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.A review of the device history record revealed no irregularities during the manufacture of the reported lot.H3 other text : see section h.10.
Event or Problem Description
Material no: 305559, batch no: 4294859.It was reported that before use of the syringe safetylok 10ml ll the expiration date is listed on the shelf pack but not on the individual product blister packs.The shelf pack has the expiration date of the syringes listed, but there is no expiration date on the individual packages.This can lead to use of expired product once the syringes are removed from the shelf pack.

• Brand Name: SYRINGE SAFETYLOK 10ML LL
• 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: 9437671
• Report Number: 1213809-2019-01234
• Device Sequence Number: 14174195
• Product Code: FMI
• UDI-Device Identifier: 30382903055594
• UDI-Public: 30382903055594
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• 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): 12/18/2019

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: 10/31/2019
• Device Model Number: 305559
• Device Catalogue Number: 305559
• Device Lot Number: 4294859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 12/18/2019
• 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