MAUDE Adverse Event Report: GEMTIER MEDICAL (SHANGHAI) INC. RELI; SAFETY BLOOD COLLECTION SET

Model Number	GSBCS23G-12
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a dull needle on a butterfly caused pain to the patient by multiple phlebotomists from one lab customer.
Additional Manufacturer Narrative
Corrected data: section e3, 02/20/2020: updated initial reporter occupation to "non-medical professional" manuacturer/importer narrative: section h10; 02/20/2020: we are moving to close this complaint file based on the corrective action taken by the factory to improve the sharpness of the cannula.Samples of the improved product were sent to a large us customer for feedback.After a reasonable attempt to get documented feedback on the improved samples from this customer, we are accepting the improvements made by the factory based on the penetration force and competitive sample test data compiled to evaluate the change.Testing results of the improvements made show an improvement in performance and are comparable with the market leader.We consider this file closed.
Event or Problem Description
It was reported that a dull needle on a butterfly caused pain to the patient by multiple phlebotomists from one lab customer.

• Brand Name: RELI
• Common Device Name: SAFETY BLOOD COLLECTION SET
• Manufacturer (Section D): GEMTIER MEDICAL (SHANGHAI) INC.; no. 18 jianding rd; fengjing town, jinshan dist.; shanghai, shanghai 20150 2; CH 201502
• MDR Report Key: 8843466
• Report Number: 1058382-2019-00003
• Device Sequence Number: 1504753
• Product Code: FMI
• UDI-Device Identifier: 00386120008646
• UDI-Public: 00386120008646
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019
• Report Date (Section F): 07/30/2019

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: 09/24/2021
• Device Model Number: GSBCS23G-12
• Device Catalogue Number: GSBCS23G-12
• Device Lot Number: 18BC001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/16/2019
• Device Age: 3 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 02/20/2020
• 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: 07/30/2019