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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MANUAL RESUSCITATOR,DURABLE INFANT W/MA

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TELEFLEX MEDICAL HUDSON MANUAL RESUSCITATOR,DURABLE INFANT W/MA Back to Search Results
Catalog Number 5347
Device Problems Device Damaged Prior to Use (2284); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/10/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device involved in this report has been returned to the manufacturer and the investigation is in progress.
 
Event Description
Customer complaint alleges that upon "opening for using the respirator was already torn, so the physician could not use it. " the alleged defect was reported as prior to use. There was no report of patient involvement.
 
Manufacturer Narrative
(b)(4). A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint. The sample was returned for evaluation. A visual exam was performed and it was observed that the respirator was torn along the neck of the bag. The products are 100% leak tested at the manufacturing facility prior to release and a defect of this type would be detected in the assembly line; therefore, the defect occurred after delivery. An attempt was made to duplicate the defect; however, the residual bags could not be torn. This defect was not caused by material aging. It was also observed that the name plate was damaged on the returned sample, indicating that the product was damaged during transportation.
 
Event Description
Customer complaint alleges that upon "opening for using the respirator was already torn, so the physician could not use it. " the alleged defect was reported as prior to use. There was no report of patient involvement.
 
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Brand NameHUDSON MANUAL RESUSCITATOR,DURABLE INFANT W/MA
Type of DeviceMANUAL RESUSCITATOR
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 Key6139307
MDR Text Key61295436
Report Number3011137372-2016-00340
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5347
Device Lot Number150323
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2017
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

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