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

Catalog Number DYNCPDS14

Device Problems Break (1069); Nonstandard Device (1420)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/22/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2022 at the end of the procedure the suction catheter broke while attached to the patient.Per the facility, 'the catheter broke causing a break in the circuit and loss of peep/oxygenation while it was replaced'.According to the facility 'the patient recovered after 100% oxygen was applied and the device was replaced with another one'.The device was in use approximately 24 hours prior to the event occurring.The device was returned for evaluation and at this time a definitive root cause could not be determined.No additional information is available.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.

Event Description

According to the facility on (b)(6) 2022 at the end of the procedure the suction catheter broke while attached to the patient.Per the facility, 'the catheter broke causing a break in the circuit and loss of peep/oxygenation while it was replaced'.

• Type of Device: CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15206439
• MDR Text Key: 297684754
• Report Number: 1417592-2022-00135
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNCPDS14
• Device Lot Number: 06921060021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: 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