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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON SHER-I-BRONCH ACCESSORY PACK; ENDOBRONCHIAL ACCESSORY PACK
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TELEFLEX MEDICAL HUDSON SHER-I-BRONCH ACCESSORY PACK; ENDOBRONCHIAL ACCESSORY PACK Back to Search Results
Catalog Number 5-16142
Device Problems Detachment Of Device Component (1104); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2014
Event Type  malfunction  
Event Description
The customer alleges that during an operation, the catheter mounts from the double lumen tubes came apart.No report of a pt injury.
 
Manufacturer Narrative
(b)(4).The device sample was rec'd but the mfr, but the investigation is incomplete at the time of this report.The device history record investigation did not show issues related to complaint.The device was mfg on 11/13/2013.
 
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Brand Name
HUDSON SHER-I-BRONCH ACCESSORY PACK
Type of Device
ENDOBRONCHIAL ACCESSORY PACK
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate, b.c. 2148 7
MX   21487
Manufacturer Contact
margie burton, rn
3015 carrington mill blvd
morrisville, NC 27560
9194334965
MDR Report Key4595887
MDR Text Key15906377
Report Number3003898360-2015-00175
Device Sequence Number1
Product Code BZA
Combination Product (y/n)N
Reporter Country CodeNZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5-16142
Device Lot Number1528589
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/19/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received02/10/2015
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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