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

Model Number 1423028

Device Problems Contamination (1120); Material Fragmentation (1261)

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

Event Date 07/11/2019

Event Type  malfunction  

Event Description

On two separate dates, materials management identified secondary iv tubing sets 14230-28 from icu medical that had hardened black spots of residue in operating room on the drip chamber differing from the cloudy chambers previously identified in last year.Residue has not been identified by icu medical at this time.Icu medical claims to visually check 100% of their products post-manufacturing.

• Brand Name: LIFESHIELD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC.; highway 301 north; rocky mount NC 27801
• MDR Report Key: 8915188
• MDR Text Key: 155035177
• Report Number: 8915188
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1423028
• Device Catalogue Number: 14230-28
• Device Lot Number: 3894617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1