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

Model Number SN18G151

Device Problems Contamination (1120); Dull, Blunt (2407)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer stated they conduct coring testing on each lot prior to release, and document the results in a verification report.Also, since the complaint was reported the manufacturer has conducted testing on retain samples and have not been able to reproduce the reported coring issue.The manufacturer will examine the returned sample of the needle/syringe and medication vial stopper to conduct a root cause analysis.

Event Description

It was reported the blunt fill needle was coring on multiple lot numbers and multiple brands of medication vial tops.

Event Description

It was reported that prior to an injection to the patient, the blunt fill needle was coring the medication vial stopper.A small peice of unidentified debris was found in the syringe.The clinitian stated this happened multiple times over the past few months.No reports of patient injury or medical intervention have been reported due to this issue.

Manufacturer Narrative

The manufacturer stated they conduct coring testing on each lot prior to release, and document the results in a verification report.Also, since the complaint was reported the manufacturer has conducted testing on retain samples and have not been able to reproduce the reported coring issue.The manufacturer will examine the returned sample of the needle/syringe to conduct a root cause analysis.Corrected data: (b)(6) 2018.1.Incorrect catalog number entered on original report.Suspect device catalog number updated from (b)(4) 2.Incorrect udi number associated with the device input on the original report.(b)(4) is a class i device and is not required to have a udi listed with gudid at this time, so the udi information was removed from the original report.

Manufacturer Narrative

The manufacturer stated they conduct coring testing on each lot prior to release, and document the results in a verification report.Also, since the complaint was reported the manufacturer has conducted testing on retain samples and have not been able to reproduce the reported coring issue.The manufacturer will examine the returned sample of the needle/syringe to conduct a root cause analysis.Corrected data: 08/10/2018: 1.Incorrect catalog number entered on original report.Suspect device catalog number updated from sn18g151 to bfn18g151.2.Incorrect udi number associated with the device input on the original report.Bfn18g151 is a class i device and is not required to have a udi listed with gudid at this time, so the udi information was removed from the original report.Additional narrative: 09/26/2018: an on-site audit was conducted at the factory (b)(6) 2018, overseen by representatives from the customer's group purchasing organization's sourcing team in cooperation with myco qa/ra staff.Coring testing of the device was conducted using an approved test protocol during this time and was also overseen by epresentatives from the customer's group purchasing organization's sourcing team.The purpose of this audit was: 1) to assess the operational conformance and the effectiveness of the factory's quality management system, and the overall capability to meet the requirements of the customer's appointed partners and industry requirements applicable to the products the factory provides, and 2) review the dhr records to ensure no changes were made to the production processes.There were no major or minor findings.Coring testing was completed during this audit, and no coring was reported.The factory tested 135 pcs from a current production lot (#yp180826) and 15pcs from the lot retains for the reported lot (#170820).One (1 ) needle was used to make 4 punctures; 1 needle per vial.This method represents the worst-case use scenario.No coring issue was reported using this method.Additional coring testing was completed by testing 540 pcs from production lot (#yp180826) and 60pcs from lot #170820 for 1 needle per stick; 4 needles per vial testing.This testing method simulates the method most commonly used.No coring was reported.The testing was completed by factory engineers and overseen by members of thecustomer's group purchasing organization's sourcing team.The factory was unable to review the complaint sample returned by the end-user as it did not make it through chinese customs inspections.We are working with the factory to have the sample returned but it has most likely been destroyed by these authorities.Please note , additional steps were taken to identify coring potential.Coring during use can be affected by many factors such as the quality of the needle, the quality of the vial stopper, the angle of the needle during penetration, and the area of the vial stopper punctured.Coring of the test vial stopper was achieved by inserting the needle at a severe angle inconsistent with proper technique.The root cause of the coring is most likely to be improper insertion of the cannula into the vial stopper, or insertion of the cannula into the vial stopper in a manner inconsistent with the instruction for use (ifu).A review of the batch records, review of the production processes, and the coring test results indicate the coring was not caused by a quality issue with the needle.Based on the audit result at the factory, no coring of the test vials by the production samples or the retained samples of the needles, and no further complaints reported for this issue, we have closed the complaint file and are moving to close this report.No further action will be taken at this time.Copies of the testing reports will be uploaded as evidence of the results.Corrected data: (b)(6) 2018, revision of section d10 from yes (sample is available) to no (sample is not available) for review by manufacturer.The sample did not clear china customs and attempts to have the sample returned have been denied.The complaint sample is presumed to have been destroyed.- attachment: [cpl#18072701.54a_reli coring test protocol_15aug2018.Pdf, cpl#18072701.54b_coring testing by hts.Pdf, cpl#18072701.54c_coring testing pictures.Pdf].

Event Description

It was reported that prior to an injection to the patient, the blunt fill needle was coring the medication vial stopper.A small peice of unidentified debris was found in the syringe.The clinitian stated this happened multiple times over the past few months.No reports of patient injury or medical intervention have been reported due to this issue.

• Brand Name: RELI
• Type of Device: 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: 7770549
• MDR Text Key: 116715004
• Report Number: 1058382-2018-00005
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 00386120007205
• UDI-Public: 00386120007205
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2018,08/26/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2022
• Device Model Number: SN18G151
• Device Catalogue Number: BFN18G151
• Device Lot Number: 170820
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/09/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2018
• Distributor Facility Aware Date: 07/27/2018
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/10/2018; 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1