MAUDE Adverse Event Report: OHIO MEDICAL LLC HOSE RETRACTOR

Model Number HS-RET-HD

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Event Description

Ohio medical llc was contacted on december 10, 2021 regarding a hose retractor zip tie breaking and a piece of plastic falling on a patient.An investigation was initiated.On january 6, 2022 the ohio medical quality engineer spoke with the representative of (b)(6).The hs-ret-hd hose retractor is an accessory to the ohio medical hose assembly.It is used to suspend excess medical gas hose overhead when not in use, to avoid interference with activities in the space below.The retractor is mounted to the overhead medical gas outlet alongside the hose connection.The hose is secured to the end of the spring loaded retractor cable by a short length of tubing and cable tie.The result of the interview determined that the plastic zip tie broke and a small piece of plastic fell onto the patient.The hose and hose retractor remained attached to the ceiling as required.No injury or other adverse consequence occurred as a result of the broken zip tie.

• Brand Name: HOSE RETRACTOR
• Type of Device: HOSE RETRACTOR
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• Manufacturer (Section G): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• Manufacturer Contact: jessica barrile ; 1111 lakeside dr; gurnee, IL 60031 ; 8478556318
• MDR Report Key: 13239953
• MDR Text Key: 286439301
• Report Number: 1419185-2022-00001
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HS-RET-HD
• Device Catalogue Number: HS-RET-HD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1