MAUDE Adverse Event Report: J & J INSTRUMENTS, LLC ASPIRATING SYRINGE TYPE CW

Model Number	100-9808
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a dental extraction procedure a dental assistant's finger was pricked by a needle attached to their 100-9808 aspirating syringe.The assistant disinfected their finger, self-applied a bandage, and was referred to visit their primary care physician.
Additional Manufacturer Narrative
Two syringes were returned by the customer for evaluation.The evaluation determined that the syringe showed signs of cross threading where the needle attaches which may have caused or contributed to the reported event.The lot history record was reviewed and confirmed the lot was manufactured to specification.The cross threading may have been caused by mishandling by user facility personnel.Additionally, the employee should have ensured the needle was capped during handling.The instructions for use state, "warning to avoid needle sticks, re-cap needle after injection has been given.Precautions keep needle capped while affixing or removing from syringe.".

• Brand Name: ASPIRATING SYRINGE TYPE CW
• Common Device Name: SYRINGE
• Manufacturer (Section D): J & J INSTRUMENTS, LLC; 120 goodwin place; stratford CT 06615
• Manufacturer (Section G): J & J INSTRUMENTS, LLC; 120 goodwin place; stratford CT 06615
• Manufacturer Contact: daniel davy ; 120 goodwin place; stratford, CT 06615 ; 4403927453
• MDR Report Key: 16763790
• Report Number: 2246990-2023-00001
• Device Sequence Number: 6034394
• Product Code: EJI
• UDI-Device Identifier: 00304040004456
• UDI-Public: 00304040004456
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 100-9808
• Device Catalogue Number: 1009808
• Device Lot Number: 0522A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown