MAUDE Adverse Event Report: PROGRESSIVE MEDICAL, INC. MANIFOLD MULTIPORT Q2 10 IN 6 PORTS IV NEEDLE FREE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 9520

Device Problem Break (1069)

Patient Problems Tachycardia (2095); Low Oxygen Saturation (2477); Increased Respiratory Rate (2486)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

Upon return to the post anesthesia care unit (pacu) from the operating room (or), the patient began having decreased oxygen saturation (o2 sats), increased heart rate and respirations.Upon further assessment it was noted that the right double lumen central line had visible air bubble- bubble aspirated, line had good blood return.When looking closer at the central line set up, the purple 6 port "multi-port" fluid adapter was noted to have a broken blue port, open to air.Unable to locate the blue part of the adapter.

• Brand Name: MANIFOLD MULTIPORT Q2 10 IN 6 PORTS IV NEEDLE FREE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): PROGRESSIVE MEDICAL, INC.; 997 horan drive; fenton MO 63026
• MDR Report Key: 13618365
• MDR Text Key: 286232641
• Report Number: 13618365
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9520
• Device Catalogue Number: 9520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White