BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA SYSTEM, CONNECTOR, C35-O

    MDR report key: 8897008 · Received August 15, 2019

    Report

    Report Number
    2243072-2019-01718
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 27, 2019
    Report Date
    October 10, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.4. DESCRIBE EVENT OR PROBLEM: MATERIAL NO.: 515070; BATCH NO.: 1904103. IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ OPTIMA SYSTEM, CONNECTOR, C35-O, THE N35-O INFUSION SET DISCONNECTED. THIS OCCURRED ON 9 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. COMPLAINT 11 OF 14: COMPLAINT FORM 14 (CONNECTOR). PATIENT WAS RECEIVING A 24HR INFUSION ON AN IP UNIT. INFUSION DISCONNECTED AT THE CONNECTOR/INJECTOR CONNECTION CLOSE TO THE 24HR MARK. NO LEAK OCCURRED, AND NO PATIENT OR NURSE INJURY. SITE LEGAL NAME (FDA): BECTON DICKINSON, S.A. - SAN AGUSTIN DE GUADALIX, SPAIN / 28750. D.1. MEDICAL DEVICE BRAND NAME: BD PHASEAL¿ OPTIMA SYSTEM, CONNECTOR, C35-O; D.2. MEDICAL DEVICE TYPE: ONB; D.2. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET; D.3. MEDICAL DEVICE MANUFACTURER: SAN AGUSTIN; D.2. MEDICAL DEVICE CATALOG #: 515070; D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31; D.4. MEDICAL DEVICE LOT #: 1904103; D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4); G.1. MANUFACTURING LOCATION: SAN AGUSTIN; G.5. PMA/510(K)#: K181221; H.4. DEVICE MANUFACTURE DATE: 2019-04-29. H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1904103, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED, ENGAGING AND DISENGAGING THE CONNECTORS AND SAMPLE INJECTORS FROM LOT 1807712. IN ALL CASES THE PRODUCT FUNCTIONED PROPERLY, AND NO ISSUES WERE OBSERVED. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. CAPA 1186628 HAS BEEN OPENED TO DOCUMENT THE INVESTIGATION REGARDING INJECTOR/CONNECTOR SEPARATION FAILURE MODE.

    Description of Event or Problem · 0

    MATERIAL NO.: 515070; BATCH NO.: 1904103. IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ OPTIMA SYSTEM, CONNECTOR, C35-O, THE N35-O INFUSION SET DISCONNECTED. THIS OCCURRED ON 9 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. COMPLAINT 11 OF 14: COMPLAINT FORM 14 (CONNECTOR). PATIENT WAS RECEIVING A 24HR INFUSION ON AN IP UNIT. INFUSION DISCONNECTED AT THE CONNECTOR/INJECTOR CONNECTION CLOSE TO THE 24HR MARK. NO LEAK OCCURRED, AND NO PATIENT OR NURSE INJURY.

    Description of Event or Problem · 0

    MATERIAL NO.: 515070; BATCH NO.: 1904103. IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ OPTIMA SYSTEM, CONNECTOR, C35-O, THE N35-O INFUSION SET DISCONNECTED. THIS OCCURRED ON 9 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. COMPLAINT 11 OF 14: COMPLAINT FORM 14 (CONNECTOR). PATIENT WAS RECEIVING A 24HR INFUSION ON AN IP UNIT. INFUSION DISCONNECTED AT THE CONNECTOR/INJECTOR CONNECTION CLOSE TO THE 24HR MARK. NO LEAK OCCURRED, AND NO PATIENT OR NURSE INJURY.

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    MATERIAL NO.: UNKNOWN. BATCH NO.: UNKNOWN. (REPORTED - 1904103) IT WAS REPORTED THAT DURING USE OF THE UNSPECIFIED BD¿ BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O INFUSION SET DISCONNECTED. THIS OCCURRED ON 9 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. COMPLAINT 11 OF 14: COMPLAINT FORM 14 (CONNECTOR) PATIENT WAS RECEIVING A 24HR INFUSION ON AN IP UNIT. INFUSION DISCONNECTED AT THE CONNECTOR/INJECTOR CONNECTION CLOSE TO THE 24HR MARK. NO LEAK OCCURRED, AND NO PATIENT OR NURSE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693483 BD PHASEAL¿ OPTIMA SYSTEM, CONNECTOR, C35-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1904103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other