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	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 was leaking.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 309606 batch no: unknown (reported 8266957).It was reported that the syringe was leaking.Spoke with customer on 03/28 and it was noted that this was discovered before use and that the event date is not know.No other information is available per the customer.
Event or Problem Description
It was reported that bd¿ safety-lok¿ bd¿ disposable syringe with bd luer-lok¿ tip was leaking.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 309606 batch no: unknown (reported 8266957) it was reported that the syringe was leaking.Spoke with customer on 03/28 and it was noted that this was discovered before use and that the event date is not know.No other information is available per the customer.
Additional Manufacturer Narrative
Investigation: 98 sealed packaged 3ml safety-lok syringes were received, confirmed to be from batch #8266957 (p/n 309606).Each syringe was individually evaluated.No damage or molding defects were observed in any of the 98 returned syringes.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/pulling in air is not associated with manufacturing process but is possibly associated with end user¿s connecting product to the needle/other mating device.The reported defect was not identified in the samples received.

• 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: 8499302
• Report Number: 1213809-2019-00425
• Device Sequence Number: 1628881
• 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): 04/30/2019

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: 04/02/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 04/30/2019
• 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