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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MANUAL RESUSCITATOR,DURABLE CHILD W/MAS; MANUAL RESUSCITATION BAG
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TELEFLEX MEDICAL HUDSON MANUAL RESUSCITATOR,DURABLE CHILD W/MAS; MANUAL RESUSCITATION BAG Back to Search Results
Catalog Number 5346
Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been returned, 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 device evaluation.
 
Event Description
Customer complaint alleges the "mask is not connected with the bag tightly, so it slides easily".Alleged malfunction reported as detected prior to use, during functional testing.No report of patient involvement.There was no report of patient injury or consequence.
 
Manufacturer Narrative
(b)(4).Corrected data: lot# corrected to 100906.The sample was returned for evaluation.The mask was not returned.The dimension of the connector was checked and it was found to be within specification.It was also noticed that the product was out of expiration.The product was manufactured in september 2010 (lot number 100906).The manufacturing records were reviewed and there were no issues found that could be related to the reported complaint.Because the mask was not returned, a full investigation could not be conducted and a root cause was not determined.
 
Event Description
Customer complaint alleges the "mask is not connected with the bag tightly, so it slides easily".Alleged malfunction reported as detected prior to use, during functional testing.No report of patient involvement.There was no report of patient injury or consequence.
 
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Brand Name
HUDSON MANUAL RESUSCITATOR,DURABLE CHILD W/MAS
Type of Device
MANUAL RESUSCITATION BAG
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6784018
MDR Text Key82671342
Report Number3011137372-2017-00251
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K895589
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5346
Device Lot Number100906
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received09/14/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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