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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TRACHEOSTOMY PVC - PORTEX TUBES PDT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

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SMITHS MEDICAL ASD, INC. TRACHEOSTOMY PVC - PORTEX TUBES PDT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Catalog Number 100/563/070
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2018
Event Type  malfunction  
Manufacturer Narrative
Udi information is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A total of five (5) product samples were received for evaluation.Visual inspection was performed.The evaluation received 5 components from the customer.The damage to the returned complaint object was confirmed.The sample for this complaint was sent to the manufacturing site, who will carried out a full investigation into the reported issue based on the sample which was returned.Oem evaluated the returned device for further analysis and upon visual inspection observed one tear in the cuff.A review of the manufacturing process was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.Inflation test was audited during thirty-two (32) units, in order to verify that the inflation test was properly performed; the inflation test was performed according to the test method stated in the manufacturing procedure; no deflated cuffs were detected during the thirty-two (32) units tested.The root cause was unable to be undetermined.Actions taken to mitigate the reported issue: no corrective action is required as there is no information to suggest that the product become damaged during manufacture since product is 100% deflated and inspection.A preventive action a notification to production personnel was conducted by the quality engineer in order to create awareness about failure mode issue reported by the customer.
 
Event Description
It was reported that the product was received in a damaged state.No patient injury was reported.
 
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Brand Name
TRACHEOSTOMY PVC - PORTEX TUBES PDT
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
jim vegel
6000 nathan lane north
no-258/a, bomsandra indst. are
minneapolis, MN 55442
MDR Report Key15599258
MDR Text Key307035459
Report Number3012307300-2022-23883
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K173384
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/13/2022
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 Health Professional
Device Catalogue Number100/563/070
Device Lot Number3556937
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/26/2022
Initial Date FDA Received10/13/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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