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

Model Number	515085
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For oem manufacturing sites: (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd phaseal¿ optima infusion clamp m25-o the clamps are not snapping closed.This occurred with 10 clamps.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that many of the infusion clamps are not snapping close.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-05-21.H6: investigation summary: one sample was provided to our quality team for investigation.Upon visual inspection, the latch mechanism was observed to be bent.A review of lot 2004106 was performed, all samples were 100% inspected for product function and no deviations were identified during the manufacturing of this lot that could contribute to the reported failure.Twenty five samples of lot 2004106 were used for additional evaluation, all product was inspected and no samples was observed to have a bent locking mechanism.Based on our quality team's investigation, it likely the latch bent due to force applied to the device while in the incorrect position.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that while using bd phaseal¿ optima infusion clamp m25-o the clamps are not snapping closed.This occurred with 10 clamps.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that many of the infusion clamps are not snapping close.

• Brand Name: BD PHASEAL OPTIMA INFUSION CLAMP M25-O
• Common Device Name: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11823075
• Report Number: 2243072-2021-01461
• Device Sequence Number: 1321681
• Product Code: KMK
• UDI-Device Identifier: 00382905150852
• UDI-Public: 00382905150852
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 06/24/2021

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 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: 05/21/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1