MAUDE Adverse Event Report: GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD; SYRINGE/NDL, SAFETY 1CC 23GX1"

Catalog Number NRSS1-23G25

Device Problem Fail-Safe Problem (2936)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

Mckesson medical surgical is the assembler of a convenience kit on behalf of the sns that includes this safety syringe.Haiou medical is the manufacturer of the syringe.Mckesson medical-surgical does not undertake any further manufacturing or relabeling of the syringe.We have notified asprsnsowsopscell@cdc.Gov and barda-rqaproductacceptance@hhs.Gov who will pass along this information to haiou medical, the manufacturer of the syringe so they may conduct a device evaluation as warranted.

Event Description

Customer reported multiple cases where the plunger will not pull back.One case reported that the needle broke free from the syringe and remained in the patient's arm.

• Type of Device: SYRINGE/NDL, SAFETY 1CC 23GX1"
• Manufacturer (Section D): GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD; nanyuan industrial zone; north liusha; punning city, guangdong 51530 0; CH 515300
• Manufacturer (Section G): MCKESSON MEDICAL SURGICAL, INC.; 1125 sycamore road; manteno IL 60950
• Manufacturer Contact: jo silverthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 11633968
• MDR Text Key: 250228367
• Report Number: 3017368639-2021-00021
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 141349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NRSS1-23G25
• Device Lot Number: 20JC2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2020
• 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
• Patient Outcome(s): Other