MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 96000S

Device Problems Break (1069); Difficult to Flush (1251); Insufficient Flow or Under Infusion (2182); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  malfunction  

Event Description

While drawing a timed lab draw for the patient using the patient's port, the port stopped having blood return and ability to flush.During troubleshooting measures, i took off the male angel wing adapter device from the blue lure lock connector and discovered that the tip of the adapter had broken off into the port cap (blue lure lock connector).Trouble shooting measures were performed and blood return was restored.Saf-t holder device with multi-sample male luer adapter.

• Brand Name: JELCO
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9151922
• MDR Text Key: 161076257
• Report Number: 9151922
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96000S
• Device Lot Number: 3792137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA