MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC HENRY SCHEIN 3ML LUER LOCK SYRINGE W/EXCH NEEDLE TRAY 21G,1(SEALED CAP)

Model Number	900-7842
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiopharmaceutical contaminated customer syringe sample could not be evaluated.The sol-millennium production site checked the batch record of impacted 3ml luer lock syringe w/exch needle tray 21g x 1" (sealed cap), ref 900-7842, lot 18081758.The lot was produced on (b)(6) 2018 using the standard process with no anomalies found on batch documentation.Sol-millennium released this lot on 01/08/2019.Archive (retain) sample evaluation: water tightness test & airtightness test: 10 pieces of archived samples from the complaint lot were tested for the airtightness following annex b of iso 8537:2016 and for water tightness following annex e of iso (b)(4).No leakage was found in all samples tested.No anomalies were found on archive samples checked.Complaint could not be confirmed.There is no evidence of a trend.No immediate corrective action is required and no corrective action is planned.Sol-millennium will continue to monitor the product for reoccurrence.Probability of occurrence was calculated to be 1.1x10^-7 and was assessed as low.The severity has been assessed as reportable due to the potential for serious injury due to the radiopharmaceutical drug leak.
Event or Problem Description
Customer reported that there was liquid in the middle portion of the rubber grommet (gasket) on the plunger part of the syringe.The liquid was radioactive at the time.Per follow up information received, the customer said that the liquid did leak out of the barrel beyond the plunger.The radiopharmaceutical liquid leaked on the hand of the healthcare worker while they were injecting into patient.The customer confirmed that there was no report of skin contamination of the healthcare worker due to the radioactive drug leakage on the hand as the healthcare worker was wearing protective gloves.No radioactive liquid spill clean-up procedure was needed at the hospital.No injury was reported by healthcare worker.There was also no delay or interruption of patient therapy as the administration was considered completed.Although no injury was reported, this report will be filed due to the potential for occurence of a serious injury.

• Brand Name: HENRY SCHEIN 3ML LUER LOCK SYRINGE W/EXCH NEEDLE TRAY 21G,1(SEALED CAP)
• Common Device Name: LUER LOCK SYRINGE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 315 shawnee north dr; suite 100; suwanee, ga
• MDR Report Key: 10323714
• Report Number: 3014312726-2020-00002
• Device Sequence Number: 3463876
• Product Code: MEG
• UDI-Device Identifier: 00304040017203
• UDI-Public: 00304040017203
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2023
• Device Model Number: 900-7842
• Device Catalogue Number: 9007842
• Device Lot Number: 18081758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1