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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd phaseal¿ optima infusion clamp (m25-o) unclamped from the injector, which then separated from the connector after the proton pump therapy.The following information was provided by the initial reporter: "pt arrived with cadd pump disconnected.Pt stated the blue optima outer cap unclamped and the optima injector popped off from the optima connector when he got home from proton pump therapy earlier today.On arrival to atc, rn flushed the patient's picc line with no trouble or resistance.Rn replaced optima connector, tightened connections and placed a new blue optima outer cap.Infusion restarted ater reconnecting to patient.Rn monitored pt for 15 minutes after reconnection- no pump problems at this time.Rn reeducated pt.".
Additional Manufacturer Narrative
H.6.Investigation: one video received for investigation, optima connector was connected to an optima injector, the optima injector was connected to an iv line.At the moment of the connection the optima connector, popped out from the injector.No damages can be observed on optima connector nor optima injector.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.Testing results were reviewed for the reported lot and found all product met required specifications.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
It was reported that the bd phaseal¿ optima infusion clamp (m25-o) unclamped from the injector, which then separated from the connector after the proton pump therapy.The following information was provided by the initial reporter: "pt arrived with cadd pump disconnected.Pt stated the blue optima outer cap unclamped and the optima injector popped off from the optima connector when he got home from proton pump therapy earlier today.On arrival to atc, rn flushed the patient's picc line with no trouble or resistance.Rn replaced optima connector, tightened connections and placed a new blue optima outer cap.Infusion restarted ater reconnecting to patient.Rn monitored pt for 15 minutes after reconnection- no pump problems at this time.Rn reeducated pt.".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12558079
• Report Number: 3003152976-2021-00653
• Device Sequence Number: 14430190
• 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): 11/05/2021

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: Lay User/Patient
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 12/02/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PHASEAL OPTIMA CONNECTOR; PHASEAL OPTIMA INJECTOR
• Patient Sex: Unknown