MAUDE Adverse Event Report: M25-O INFUSION CLAMP; INTRAVASCULAR CATHETER SECUREMENT DEVICE

Model Number	515085
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that m25-o infusion clamp mating components separated and leaked.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported by the sales representative that the injector and connector become disconnected causing violent eruption and flow issues.Per email: see below for two quality incidents that have been occurring frequently.N40 and connector when attached an pressure is applied to n40 it causes a violent eruption and the connector becomes displaced 3-5' across room.N40 and connector are coming disengaged when blue clamp m25-0 is properly engaged.The disengagement causes the iv pump to stop flowing and occlusion alarms, thus disrupting workflow and disturbing patients.
Event or Problem Description
It was reported that m25-o infusion clamp mating components separated and leaked.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported by the sales representative that the injector and connector become disconnected causing violent eruption and flow issues.Per email: see below for two quality incidents that have been occurring frequently.N40 and connector when attached an pressure is applied to n40 it causes a violent eruption and the connector becomes displaced 3-5' across room n40 and connector are coming disengaged when blue clamp m25-0 is properly engaged.The disengagement causes the iv pump to stop flowing and occlusion alarms, thus disrupting workflow and disturbing patients.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# was sent in error.The mdr for this product should not have been submitted.It was marked concomitant.This supplemental is to cancel mdr 2243072-2021-02178 h3 other text : see h10.

• Brand Name: M25-O INFUSION CLAMP
• Common Device Name: INTRAVASCULAR CATHETER SECUREMENT DEVICE
• MDR Report Key: 12375191
• Report Number: 2243072-2021-02178
• Device Sequence Number: 1232495
• Product Code: KMK
• UDI-Device Identifier: 00382905150852
• UDI-Public: 00382905150852
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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
• Operator of Device: Other
• Device Model Number: 515085
• Device Catalogue Number: 515085
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1