MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT

Catalog Number DYNCPDS14

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/13/2022

Event Type  Injury  

Event Description

It was reported that when suctioning the patient, the catheter became dislodged when pulling the catheter out of the endo tube with the suction on.The suctioning had to be terminated and a new catheter placed.

Manufacturer Narrative

It was reported that when suctioning the patient, the catheter became dislodged when pulling the catheter out of the endo tube with the suction on.The device was retrieved by the respiratory therapist with her fingers.The suctioning had to be terminated and a new catheter placed.The procedure was completed and the patient was stabilized.The facility reported that the patient is now deceased however the cause of death was unrelated to the incident.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The facility stated that they were unaware that additional details would be needed and they do not have any more information.The sample was returned for evaluation however a definitive root cause could not be determined.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Manufacturer Narrative

Recall r-22-100 was initiated related to this issue.

• Brand Name: CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT
• Type of Device: CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14758856
• MDR Text Key: 303221088
• Report Number: 1417592-2022-00084
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNCPDS14
• Device Lot Number: 06921100021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2022
• 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: Unknown
• Removal/Correction Number: R-22-100
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male