MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETY-LOK¿ 5ML SYRINGE

Catalog Number	305558
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd safety-lok¿ 5ml syringe had two labels on each package.One states ¿latex free¿ while the other doesn¿t.This was observed before use and there was no report of injury or medical interventions.
Additional Manufacturer Narrative
Results: bd received (25) twenty five packaged 5ml safety lok syringes, some appeared opened by customer.The samples were confirmed to be from batch #1203588.The samples were visually evaluated.Note: this batch has expired.The syringes were found to have an over label attached to the top web on one side.The label does not have the ¿latex free¿ statement that the original top web has.Regarding the graphics on the original top web ¿ the product was inspected, accepted and released with the original top web graphics.All information included in the original top web was accurate and correct at the time the product was released to market.The over labeling did not affect the accuracy of the original information.A review of the device history record revealed no irregularities during the manufacture of the reported lot number.Conclusion: bd was able to confirm the customer's indicated failure, however it was not a defect.Correction: lot # : 1203588.Device manufacture date: 09/02/2011.

• Brand Name: BD SAFETY-LOK¿ 5ML SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7004319
• Report Number: 1213809-2017-00246
• Device Sequence Number: 19057731
• Product Code: FMI
• UDI-Device Identifier: 30382903055587
• UDI-Public: 30382903055587
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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 Catalogue Number: 305558
• Device Lot Number: 1203588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 01/30/2018
• 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