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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY

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SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY Back to Search Results
Model Number 670180
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/05/2020
Event Type  malfunction  
Event Description
Information received a smiths medical tracheostomy|silicone - bivona tubes adult tts malfunctioned.After a week in use, a tear in the cuff was noted.No adverse patient events reported.
 
Event Description
Investigation completed and summarized in h 10.
 
Manufacturer Narrative
Investigation completed on a smiths tracheostomy|silicone - bivona tubes adult tts.Visually inspected from 12? -16? with normal lighting revealed big split and cut in cuff.Relevant documents which were reviewed and correct for testing and inspection activities.Pwi-10007254 rev.101 clean/position/adhesive cuff.Pwi-10007269 rev.100 symmetry and leak test method.Pwi-10015937 rev.100 spray of teflon and insert valve.Av-10006853 rev.101 leak testing and cuff symmetry visual aid.10018857-001 rev.100 ifu-adult tts cuff tracheostomy.Rmd-10001843 rev.100 pfmea for bivona tracheostomy tubes.The caused and theory and consideration were revealed as: bad assembly, not follow the instructions.? manufacturing defect from the molder.No corrective actions were taken.However, as part of containment, production personnel were notified by quality engineer on 10/nov/2020 as awareness of the defect reported by the customer.
 
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Brand Name
BIVONA
Type of Device
TRACHEOSTOMY
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
5700 west 23rd ave
gary IN 46406
MDR Report Key10482921
MDR Text Key205306170
Report Number3012307300-2020-08964
Device Sequence Number1
Product Code JOH
UDI-Device Identifier15021312006070
UDI-Public15021312006070
Combination Product (y/n)N
PMA/PMN Number
K944178
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number670180
Device Catalogue Number670180
Device Lot Number3869829
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/07/2020
Initial Date FDA Received09/02/2020
Supplement Dates Manufacturer Received11/12/2020
Supplement Dates FDA Received12/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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