MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL SOL-M LUER LOCK SYRINGE W/EXCH NEEDLE TRAY; SYRINGE WITH /EXCH NEEDLE TRAY

Model Number 1852110T

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems Chemical Exposure (2570); Radiation Exposure, Unintended (3164)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint information and manufacturing process information was reviewed by the (b)(4) quality engineer.The customer complaint information was reviewed and picture shows a presence of a hairline crack in the syringe barrel.From picture it is not possible to clearly define dimensions of crack.The complaint does describe when the crack was observed.If the crack was present and observed during radiopharmaceutical preparation, the syringe would be immediately excluded by competent personnel and the syringe would not be used.The crack was noticed only when force was applied to the plunger.A personnel survey by radiation safety staff showed no signs of skin contamination.So it is believed there was never any personnel skin contamination involved.The manufacturing process information was reviewed.Production site checked the batch records of impacted syringe lot#18090412.The batch was produced on 01/07/2019 using the standard process with no anomalies found on batch documentation.Sol-millennium released this lot on 02/18/2019.Total of 25pcs archived samples of complained lot#18090412 were checked via naked eye without any crack found on the barrels.The production site also randomly selected 10 pcs of archived samples to do airtightness test and water tightness test according to iso 7886-1:2017 annex b & annex d.All of 10 archived samples passed the tests.There is no evidence that crack happened during manufacturing phase.A review of complaints of the last two years reveals that only one complaint of standard syringe has been received for this issue during year 2018.Sol-millennium will continue to monitor this type of issue.The r&d quality engineer attempted to simulate the crack using different levels of force.A similar hairline was produced by striking barrel of a syringe vigorously.It was possible to reproduce liquid leakage due to this simulated hairline crack.Root cause of when the crack occurred cannot be identified.

Event Description

Sus voluntary event report number: mw5090432.A voluntary event form was received from the fda at (b)(6) by postal service mail on 11/7/2019.Per the voluntary event report, customer reported to the fda that a 5cc syringe had a hairline crack along the barrel causing leakage and contamination of the radiopharmaceutical.The integrity and sterility of the product was compromised per the customer.On 12/3/2019 additional information was received.The (b)(6) pharmacist provided a picture of the cracked syringe.The pharmacist stated that tc-99m macro aggregated albumin was the drug that was filled in the syringe.The exact drug leakage amount was not known.The end user was (b)(6) hospital.Per the pharmacist, hospital personnel was contaminated with radioactive material, but there does not appear to have been a reported injury.(b)(6) pharmacist provided the customer (end user) investigative report.Summary of (b)(6) hospital investigative report: during a procedure on (b)(6) 2019, the doctor gave the syringe a stronger push and the force of the injection leaked through the syringe at a crack defect and dose was inadvertently sprayed onto doctor.The procedure was aborted after patient needs were met and the hospital radiation safety dept was notified.The doctor was asked to wash his face to remove any contamination.A personnel survey of the doctor by radiation safety staff showed no signs of skin contamination.So it is believed there was never any personnel skin contamination involved.As per the hospital report, radiation safety representatives surveyed and decontaminated the room.Multiple areas of the floor were surveyed and identified areas were cleaned until area surveys were reading background (0.02 mr/hr) and area wipe tests were all < 117 dpm.

• Brand Name: SOL-M LUER LOCK SYRINGE W/EXCH NEEDLE TRAY
• Type of Device: SYRINGE WITH /EXCH NEEDLE TRAY
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL; 315 shawnee north dr.; suite 100; suwanee GA 30024
• Manufacturer Contact: james barley ; 315 shawnee north dr.; suite 100; suwanee, GA 30024 ; 9494333058
• MDR Report Key: 9432985
• MDR Text Key: 176237072
• Report Number: 3014312726-2019-00003
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10818392013693
• UDI-Public: 10818392013693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2024
• Device Model Number: 1852110T
• Device Lot Number: 18090412
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1