MAUDE Adverse Event Report: MICSAFE MEDICAL GROUP (CHINA) CO., INC. RELI; BLUNT FILL NEEDLE

Model Number	BFN18G151
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after injecting air and in the propofol vial and withdrawing the drug, a dark flek was visible in the empty vial.
Additional Manufacturer Narrative
Corrected data: f7 - updated to indicate this is a supplemental / follow-up report (001).H10: additional narrative from importer: we are moving to close this complaint based on the results of the customer audit of the factory(1), coring testing results completed during the audit(2), and the manufacturer's investigation results(3).A summary of these results is being provided for your information.[1.] customer audit - healthtrust china sourcing team member mr.(b)(6) conducted an on-site audit of the batch records for this batch, and several other batches both thought to be received by the facilities and in current production.He reported that there were no changes made to the raw materials used to make the device, production processes and machines, or staff involved with the manufacture and inspection of the device during and after production.He noted this product is produced largely by automation, and all systems were compliant.The dhr for the inspected lots met the requirements of their documented procedures.[2.] the factory conducted a coring test using a test protocol pre-approved by healthtrust, and was observed by the healthtrust auditor, mr.(b)(6).Fifty (50) pieces of retain samples from the suspect batch (lot#: 191030) were tested, fifty (50) pieces of retain samples from lot#: 190825, and six hundred (650) pieces of lot#: 20201026 which were currently in production.The factory test result specification allows three (3) occurrences of coring per one hundred (100) tested samples.The factory conducted the testing using three hundred (300) test vials and noted one (1) occurrence of coring from the in-process batch (lot#: 20201026).No coring was observed during the testing of the suspect batch (lot#: 191030) or the other myco batch tested (lot#: 190825).There was no evidence of a quality issue with the device from the testing result, and they conclude the one (1) occurrence of coring noted during testing may be caused by a problem with the rubber stopper of the vial.[3.] the manufacturer concluded the reli® blunt fill needle met all material and performance specifications, there was no quality issue with the device, and no corrective action is necessary.The factory test report has been attached to this report.We consider this report closed.
Event or Problem Description
It was reported that after injecting air and in the propofol vial and withdrawing the drug, a dark flek was visible in the empty vial.

• Brand Name: RELI
• Common Device Name: BLUNT FILL NEEDLE
• Manufacturer (Section D): MICSAFE MEDICAL GROUP (CHINA) CO., INC.; 802-805, building 6; no. 1678 jingshajiang rd.; shanghai, shanghai 20033 3; CH 200333
• MDR Report Key: 10680764
• Report Number: 1058382-2020-00002
• Device Sequence Number: 2962347
• Product Code: GAA
• UDI-Device Identifier: 00386120007205
• UDI-Public: 00386120007205
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020
• Report Date (Section F): 10/14/2020

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: 04/30/2024
• Device Model Number: BFN18G151
• Device Catalogue Number: BFN18G151
• Device Lot Number: 190530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/22/2020
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/14/2020