MAUDE Adverse Event Report: BD PHASEAL¿ OPTIMA INFUSION CLAMP M25-O; INTRAVASCULAR CATHETER SECUREMENT DEVICE

Model Number	515085
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one sample received for investigation, the sample was visually inspected, and the latch mechanism appeared bent/damaged.The sample was also not able to be closed.Fifteen retained samples from the same lot were evaluated, no issues or damages observed, the samples were able to be closed.Furthermore, all samples are 100% inspected for product function during manufacturing.A device history review was performed for lot 2004106, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Given that the latch was bent, the user may have applied force on the latch when the latch was not in the correct position.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that when using the bd phaseal¿ optima infusion clamp m25-o the clamp was not working correctly.The following information was provided by the initial reporter: it was reported by customer that the clamp was not working as per procedure.

• Brand Name: BD PHASEAL¿ OPTIMA INFUSION CLAMP M25-O
• Common Device Name: INTRAVASCULAR CATHETER SECUREMENT DEVICE
• MDR Report Key: 12755274
• Report Number: 3003152976-2021-00734
• Device Sequence Number: 1454376
• Product Code: KMK
• UDI-Device Identifier: 00382905150852
• UDI-Public: 00382905150852
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 10/13/2021

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: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 515085
• Device Catalogue Number: 515085
• Device Lot Number: 2004106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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