MAUDE Adverse Event Report: HOSPIRA, INC. MICROCLAVE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 12512-01

Device Problems Crack (1135); Leak/Splash (1354); Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2017

Event Type  malfunction  

Event Description

I disconnected the patient's iv fluids (nahco3 in d5w) from the microclave cap on the red lumen of his picc line.These fluids had been running continuously for about 4 days, probably connected the whole time.I screwed a flush onto the cap with no problem, tested for blood return, and flushed the lumen.When i went to reattach fluids with new tubing, i noticed that the tip of the cap had cracked and half of the plastic around the tip was missing.I couldn't find any of the pieces at bedside.There was no evidence that any fluids had leaked during infusion.Flush and blood return check had been completed the previous night (through tubing port) without incident or leakage.I told the charge rn and performed a sterile cap change to replace the broken cap.When i tried to flush through the new cap, the line was completely occluded -- would not return or flush.The charge rn and i were concerned that a piece of plastic might have somehow lodged in the lumen.The dr.Arrived on the floor not long afterward, so we discussed the situation with him and showed him the defective cap.He considered sending the patient down for line check, but we all agreed it was possible some residual blood had been left in the lumen and clotted during the cap change.He recommended trying to tpa the line.I instilled tpa and the occlusion resolved when i removed tpa 50 minutes later.This completely resolved the situation, with no evidence of harm to or impact on the patient.I saved the broken cap in a biohazard back for director follow-up.

• Brand Name: MICROCLAVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC.; highway 301 north; rocky mount NC 27801
• MDR Report Key: 7074358
• MDR Text Key: 93492858
• Report Number: 7074358
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 12512-01
• Other Device ID Number: PM30-3795 REV 01
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2017
• Event Location: Other
• Date Report to Manufacturer: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTHER, STERILE CAP CHANGE PERFORMED
• Patient Age: 30 YR