Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON SHER-I-BRONCH ACCESSORY PACK; ENDO BRONCHIAL ACCESSORY PACK
  • 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
 

TELEFLEX MEDICAL HUDSON SHER-I-BRONCH ACCESSORY PACK; ENDO BRONCHIAL ACCESSORY PACK Back to Search Results
Catalog Number 5-16142
Device Problems Break (1069); Crack (1135)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 03/09/2015
Event Type  malfunction  
Event Description
The customer alleges that the connector keeps cracking and breaking.The alleged issue was detected in the operating room and prior to patient use.No report of a patient injury or harm.
 
Manufacturer Narrative
Qn#(b)(4).The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.The device history record investigation did not show issues related to complaint.A document assessment (fema) was conducted and no changes were required.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON SHER-I-BRONCH ACCESSORY PACK
Type of Device
ENDO BRONCHIAL ACCESSORY PACK
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate, b.c. 2147 8
MX   21478
Manufacturer Contact
margie burton, rn
3015 carrington mill blvd.
morrisville, NC 27560
9194334965
MDR Report Key4652176
MDR Text Key5683236
Report Number3003898360-2015-00222
Device Sequence Number1
Product Code BZA
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5-16142
Device Lot Number73J1400258
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/25/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received03/13/2015
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
-
-