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	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 connection.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd safety-lok bd disposable syringe with bd luer-lok tip leaked at the connection.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Four sealed 3ml safety lok packaged syringes were received and confirmed to be from batch #8122590 (p/n 309606) ¿ a syringe-only product.Based on the complaint description the leakage observed was at the syringe connection with a needle.This is a no needle syringe and the needle component used is unknown.The syringes were removed from the individual syringe packages and visually evaluated.The barrel tip and luer had no signs of damage or molding issues that would cause leakage when connected to a needle.No defects were observed.The visually evaluated syringes were paired with a standard needle via luer lok.Each syringe was filled with liquid then the liquid was expelled.No leakage was observed.The reported defect was not identified in the samples received.No corrective actions recommended since product defect was not confirmed.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.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.
Additional Manufacturer Narrative
Correction: describe event or problem: it was reported that bd¿ safety-lok¿ bd¿ disposable syringe with bd luer-lok¿ tip leaked at the connection.There were 5 occurrences of this event.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd¿ safety-lok¿ bd¿ disposable syringe with bd luer-lok¿ tip leaked at the connection.There were 5 occurrences of this event.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: 7992357
• Report Number: 1213809-2018-00687
• Device Sequence Number: 1104806
• Product Code: FMI
• UDI-Device Identifier: 30382903096061
• UDI-Public: 30382903096061
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Followup
• Report Date (Section B): 01/03/2019

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: 04/30/2023
• Device Catalogue Number: 309606
• Device Lot Number: 8122590
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 10/02/2018; 10/02/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 11/29/2018; 01/03/2019
• 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