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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX EPIDURAL MINIPACKS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX EPIDURAL MINIPACKS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Catalog Number 100/391/128CZ
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/28/2020
Event Type  malfunction  
Event Description
It was reported that when attempting to connect filter to the device the locking mechanism fell off and was in no way attached.No patient injury was reported.
 
Manufacturer Narrative
No lot number was provided; therefore, device history record review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
 
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Brand Name
PORTEX EPIDURAL MINIPACKS
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
olomoucka 306
hranice 1, mesto 753 0 1
EZ  753 01
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL, LTD.
olomoucka 306
hranice 1, mesto 753 0 1
EZ   753 01
Manufacturer Contact
jim vegel
6000 nathan lane north
building 23, level 2,
minneapolis, MN 55442
MDR Report Key15310824
MDR Text Key305361912
Report Number3012307300-2022-16496
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/29/2022
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 Number100/391/128CZ
Device Lot Number3883014
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/13/2022
Initial Date FDA Received08/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/05/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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