MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	309606
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2019
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 with the use of the bd¿ safety-lok¿ bd¿ disposable syringe with bd luer-lok¿ tip there was an issue with 4 syringed leaking.
Additional Manufacturer Narrative
Investigation: three sealed cartons of 100 each and one plastic bag with 77 loose packaged 3ml syringes were received.The samples were confirmed to be from batch #8266957(b)(4).They were visually evaluated.373 syringes had no visual defects.4 syringes had small amount of visible damage around the tip, cap or luer-lok area.The samples were tested for leakage at luer.The 1 syringe with tip damage failed the leakage test.All others passed with no leakage observed.Machine logs reveal adjustments related to material handling.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.Potential root cause for leakage is associate with the damaged tip.The tip prevents proper needle to syringe assembly and allows for leakage to occur.The likely cause for the damage is associated with the material handling process prior to assembly.Corrections took place when the issue was found around material handling.
Event or Problem Description
It was reported with the use of the bd¿ safety-lok¿ bd¿ disposable syringe with bd luer-lok¿ tip there was an issue with 4 syringed leaking.

• Brand Name: BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
• 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: 8348631
• Report Number: 1213809-2019-00221
• Device Sequence Number: 16646648
• Product Code: FMI
• UDI-Device Identifier: 30382903096061
• UDI-Public: 30382903096061
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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: 08/31/2023
• Device Catalogue Number: 309606
• Device Lot Number: 8266957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 05/06/2019
• 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