UNSPECIFIED BD PRI TUBING

Additional Manufacturer Narrative

UNKNOWN MANUFACTURER: 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. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: A COMPLAINT OF TUBING VACUUMED FLAT WAS RECEIVED FROM THE CUSTOMER. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF DAMAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A MODEL OR LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED AS NO PRODUCT WAS RETURNED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT THE UNSPECIFIED BD PRI TUBING EXPERIENCED AIR IN LINE ALARM DURING USE, CLOGGING/BLOCKING/OCCLUSION, AND DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: UNKNOWN, BATCH NO.: UNKNOWN. ETOPOSIDE STARTED PER PROTOCOL. PUMP BEGAN TO ALARM AS "AIR-IN-LINE" AND "OCCLUDED." UPON ASSESSMENT, THE TUBING APPEARED TO HAVE ISSUES WITH VENTING. THE TUBING IN THE CHANNEL WAS VACCUMED FLAT AND THE CHAMBER WAS CONCAVED IN AS WELL. INFUSION STOPPED. PHARMACY NOTIFIED. PHARMACY RECOMMENDED TO DISCONNECT AND DELIVERED TO THEM. NO ADVERSE EVENT OR HARM TO PT. PT STABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE UNSPECIFIED BD PRI TUBING EXPERIENCED AIR IN LINE ALARM DURING USE, CLOGGING/BLOCKING/OCCLUSION, AND DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: UNKNOWN BATCH NO.: UNKNOWN ETOPOSIDE STARTED PER PROTOCOL. PUMP BEGAN TO ALARM AS "AIR-IN-LINE" AND "OCCLUDED." UPON ASSESSMENT, THE TUBING APPEARED TO HAVE ISSUES WITH VENTING. THE TUBING IN THE CHANNEL WAS VACCUMED FLAT AND THE CHAMBER WAS CONCAVED IN AS WELL. INFUSION STOPPED. PHARMACY NOTIFIED. PHARMACY RECOMMENDED TO DISCONNECT AND DELIVERED TO THEM. NO ADVERSE EVENT OR HARM TO PT. PT STABLE.

Additional Manufacturer Narrative

H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF DAMAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A MODEL OR LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED AS NO PRODUCT WAS RETURNED. H3 OTHER TEXT : SEE H.10