MAUDE Adverse Event Report: HOSPIRA, INC. (ICU MEDICAL, INC) PLUM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1468728

Device Problem Hole In Material (1293)

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

Event Date 03/02/2018

Event Type  malfunction  

Event Description

Small pinhole found when priming iv tubing.Primary plum set, lot # 830735h.

• Brand Name: PLUM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC. (ICU MEDICAL, INC); 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 7457747
• MDR Text Key: 106432722
• Report Number: 7457747
• 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: Other
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/01/2020
• Device Model Number: 1468728
• Device Catalogue Number: 1468728
• Device Lot Number: 830735H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 35 YR