MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INFUSION CLAMP (M25-O); INTRAVASCULAR CATHETER SECUREMENT DEVICE

Model Number	515085
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd phaseal¿ optima infusion clamp (m25-o) wouldn't clamp during use.This occurred on 7 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: i was speaking with one of our atc nurses today and she reported recent issues with some of the blue clamps not clamping.
Event or Problem Description
It was reported that bd phaseal¿ optima infusion clamp (m25-o) wouldn't clamp during use.This occurred on 7 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: i was speaking with one of our atc nurses today and she reported recent issues with some of the blue clamps not clamping.
Additional Manufacturer Narrative
H.6.Investigation summary no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
Additional Manufacturer Narrative
Correction: after further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.A disconnecting clamp is not considered to be a reportable malfunction; therefore, the complaint will be cancelled.
Event or Problem Description
It was reported that bd phaseal¿ optima infusion clamp (m25-o) wouldn't clamp during use.This occurred on 7 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: i was speaking with one of our atc nurses today and she reported recent issues with some of the blue clamps not clamping.

• Brand Name: BD PHASEAL¿ OPTIMA INFUSION CLAMP (M25-O)
• Common Device Name: INTRAVASCULAR CATHETER SECUREMENT DEVICE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10066972
• Report Number: 3003152976-2020-00210
• Device Sequence Number: 3923454
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2022

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
• Operator of Device: Health Professional
• Device Model Number: 515085
• Device Catalogue Number: 515085
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 04/27/2020; 05/11/2022
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 05/27/2020; 05/23/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown