MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; RESTRAINT, PROTECTIVE

Lot Number 33021120001

Device Problems Break (1069); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2022

Event Type  malfunction  

Event Description

Rn had left room to get patient's pm meds, patient adequately sedated and restrained and intubated.Ventilator began alarming shortly after, charge rn and primary rn ran back to room to assess patient.He was sitting upright in bed with right had attempting to pull out ett.Right wrist restraint clip had broken, and patient was able to freely move hand, going directly to remove ett.Rns and additional staff able to restrain patient until thicker restraints able to be applied and patient was re-sedated.Ett placement verified by cxr and remained in place, but equipment had been damaged by patient and required replacements by respiratory therapy.

• Brand Name: MEDLINE
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15796974
• MDR Text Key: 303636976
• Report Number: 15796974
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2022

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 Lot Number: 33021120001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11315 DA
• Patient Sex: Male