• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHANGHAI JIANZHONG MEDICAL PACKAGING CO, LTD MCKESSON BRANDS POUCH, SELF SEAL ECON 3.5X9

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SHANGHAI JIANZHONG MEDICAL PACKAGING CO, LTD MCKESSON BRANDS POUCH, SELF SEAL ECON 3.5X9 Back to Search Results
Catalog Number 16-6423
Device Problem Fire (1245)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2020
Event Type  Injury  
Event Description
Customer reported that their self seal sterilization pouches caught fire in their ritter m7 speedclave autoclave (serial # (b)(4)). Upon opening the machine she noticed that the bags were burning. She then put the autoclave on a cart and took it outside. The autoclave was reported to be 10 years old. Mckesson contacted the manufacturer of the autoclave to bring this to their attention as well. They indicated that the unit was built and shipped in 2003 (17 years ago). They indicated that there is potential for the operator to turn the unit on without water in the chamber, which would result in the chamber getting very hot. There is also the potential for a valve or gasket to not seal completely and allow the water that was initially in the chamber to escape and allow the chamber to get very hot.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMCKESSON BRANDS
Type of DevicePOUCH, SELF SEAL ECON 3.5X9
Manufacturer (Section D)
SHANGHAI JIANZHONG MEDICAL PACKAGING CO, LTD
bldg.16 789# puxing road
minhang district
shanghai, shanghai 20111 4
CH 201114
MDR Report Key9779313
MDR Text Key181729965
Report Number1451040-2020-00002
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/03/2020,03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/06/2021
Device Catalogue Number16-6423
Device Lot NumberCJZI11-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2020
Distributor Facility Aware Date02/18/2020
Device Age4 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/03/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/03/2020 Patient Sequence Number: 1
-
-