MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP

Catalog Number	309606
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
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 bd¿ safety-lok¿ bd¿ disposable syringe with bd luer-lok¿ tip leaked at the hub during use.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Dhr: release date: 8/28/2018.Released quantity was 215,200.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 8222575 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.
Event or Problem Description
It was reported that bd¿ safety-lok¿ bd¿ disposable syringe with bd luer-lok¿ tip leaked at the hub during use.No serious injury or medical intervention was reported.

• Brand Name: BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8180365
• Report Number: 1213809-2018-00929
• Device Sequence Number: 1406906
• Product Code: FMI
• UDI-Device Identifier: 30382903096061
• UDI-Public: 30382903096061
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/20/2019

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: 07/31/2023
• Device Catalogue Number: 309606
• Device Lot Number: 8222575
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 03/20/2019
• 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