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

Model Number BFN18G151

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2019

Event Type  malfunction  

Event Description

It was reported that the rn drew up solu-medrol from a vial into a 3cc syringe using the blunt fill needle.Rn noticed a sliver of red material which appears to be a piece of the stopper floating in the fluid in the syringe.The medication was not administered to the patient.

Event Description

It was reported that the rn drew up solu-medrol from a vial into a 3cc syringe using the blunt fill needle.Rn noticed a sliver of red material which appears to be a piece of the stopper floating in the fluid in the syringe.The medication was not administered to the patient.

Manufacturer Narrative

Coring testing was completed on retained samples from the same batch and no coring was observed.The test was conducted using the company test protocol in accordance with iso 7864 and using us sourced test vials.The retained batch samples were compared to the returned suspect defect sample under magnification for any visible defect in the cutting edge of and no defects to either the returned sample or the retain batch samples were observed.All met specification for the magnification check.Dhr and raw material records for the lot were audited and found to be in order; no changes were made to approved specifications.Based on their investigation, the manufacturer concludes needle quality was not the root cause.

Manufacturer Narrative

Coring testing was completed on retained samples from the same batch and no coring was observed.The test was conducted using the company test protocol in accordance with iso 7864 and using us sourced test vials.The retained batch samples were compared to the returned suspect defect sample under magnification for any visible defect in the cutting edge of and no defects to either the returned sample or the retain batch samples were observed.All met specification for the magnification check.Dhr and raw material records for the lot were audited and found to be in order; no changes were made to approved specifications.Based on their investigation, the manufacturer concludes needle quality was not the root cause.Additional narrative: no further action will be taken by the manufacturer as the product met specification and no root cause was determined.Both the distributor customer and end-user facility have been notified of the complaint file closure.We consider this file to be closed.

Event Description

It was reported that the rn drew up solu-medrol from a vial into a 3cc syringe using the blunt fill needle.Rn noticed a sliver of red material which appears to be a piece of the stopper floating in the fluid in the syringe.The medication was not administered to the patient.

• Brand Name: RELI BLUNT FILL NEEDLE
• Type of Device: BLUNT FILL NEEDLE
• Manufacturer (Section D): MICSAFE MEDICAL GROUP (CHINA) CO. INC.; 802-805, building 6; no.1678 jingshajiang rd.; shanghai, 20033 3; CH 200333
• MDR Report Key: 8900924
• MDR Text Key: 154553114
• Report Number: 1058382-2019-00004
• Device Sequence Number: 1
• Product Code: GAA
• 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: 08/16/2019,09/05/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• Device Model Number: BFN18G151
• Device Lot Number: 190415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2019
• Distributor Facility Aware Date: 08/08/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/05/2019; 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1