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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON RESUSCITATOR BAG ADULT W/; RESUSCITATOR BAG, MANUAL
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TELEFLEX MEDICAL HUDSON RESUSCITATOR BAG ADULT W/; RESUSCITATOR BAG, MANUAL Back to Search Results
Catalog Number 157100300
Device Problem Air Leak (1008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Additional clarification of the event requested and received states: "at the end of the bag where the 02 reservoir is there is a plastic disk with the valves in it.It attaches to the bag portion that you squeeze.Where these two join it is not sealing and air leaks and you are not able to build any pressure." the device involved has been returned to the manufacturer, however the investigation of said device is still in progress at the time of this report.A follow up report will be submitted at the conclusion of the evaluation.
 
Event Description
Customer complaint alleges "not making a seal and when ventilating the air flows back into the reservoir bag." alleged issue reported as occurred during use.There was no report of patient injury or consequence.
 
Event Description
Customer complaint alleges "not making a seal and when ventilating the air flows back into the reservoir bag." alleged issue reported as occurred during use.There was no report of patient injury or consequence.
 
Manufacturer Narrative
(b)(4).The device was returned and forwarded to the contract manufacturer ((b)(4)) for investigation.(b)(4) reports the following: received one unit from teleflex.No label nor identifying information with unit.When pressure testing, unit would not pressurize and air leakage was discovered where the intake valve assembly connected to the adult bag portion.Closer inspection revealed that the bag protruded from the glued two-part valve assembly.Total separation of the adult bag from the intake valve assembly was difficult to perform but was possible when applying excessive force.Attempting to replicate this issue with a fully functional rescuer branded bvm (identically manufactured device) was possible but with significant and excessive effort.Once the bag was removed, it was not possible to replace it to the condition that was sent to (b)(4) as the adult bag would not reseat into the channel of the intake valve assembly.Report from the contract manufacturer was inconclusive as each device is checked prior to final packaging at the manufacturing facility.(con't) other remarks: (b)(4) received one faulty device of the 4 that were reported for our inspection process to occur.The description of the issue was similar between all four products.No lot # was provided for any of the four devices and all issues were generated by the same end user.All four devices were presumed to have been treated (stored and tested) in a similar fashion.(b)(4) was only able to replicate the defect by using excessive strength to pull apart the sealed components.The strength required to deploy the device is significantly less than what was used to duplicate the leak as reported.It is felt that while the defect could be duplicated, the strength required to deploy the device would not be duplicated in the field unless the user intended to damage the product.The role of the manufacturing deviation on the risk of separation is difficult to determine.The resulting investigation is inconclusive although the contract manufacturer was notified and made aware of the faulty device.
 
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Brand Name
HUDSON RESUSCITATOR BAG ADULT W/
Type of Device
RESUSCITATOR BAG, MANUAL
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key7412269
MDR Text Key105163752
Report Number3011137372-2018-00100
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
PMA/PMN Number
K993194
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number157100300
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2018
Date Manufacturer Received05/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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