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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. BREATHING CIRCUITS
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SMITHS MEDICAL INTERNATIONAL, LTD. BREATHING CIRCUITS Back to Search Results
Catalog Number C49101320J
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2020
Event Type  malfunction  
Event Description
Information received a smiths medical breathing|portex general anesthesia circuits reported by customer that the product was working properly at precheck, however when pulling on the corrugated tube with normal force, it was torn.No patient injury was reported.
 
Manufacturer Narrative
Two photos and a sample were returned for analysis.A circuit could be seen broken in the pictures.The sample was returned broken.Based on the sample provided, physically evaluation, the most probable cause is that the product became damaged after it left the manufacturing facility.No corrective actions are required since failure mode is not attributable at the manufacturing process since all products are 100% leak tested; if a tear damages a circuit surface couldn't pass the leak test.
 
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Brand Name
BREATHING CIRCUITS
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
MDR Report Key11517595
MDR Text Key242669082
Report Number3012307300-2021-02242
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 04/29/2021
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 Catalogue NumberC49101320J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/17/2021
Initial Date FDA Received03/18/2021
Supplement Dates Manufacturer Received03/31/2021
Supplement Dates FDA Received04/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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