MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VIAFLEX; SET, IV FLUID TRANSFER - VIAFLEX

Model Number 2B1307

Device Problems Chemical Spillage (2894); Device Dislodged or Dislocated (2923)

Patient Problem Chemical Exposure (2570)

Event Date 08/17/2015

Event Type  malfunction  

Event Description

Employee removed the medication with phaseal spike and secondary iv set from the hazardous medications bag in preparation to hang the bag.As she was hanging the bag, the spike dislodged from the bag spilling the contents on to the patient, patient family member, and employee.Manufacturer response for iv bag, viaflex (per site reporter): from a letter materials manager: baxter quality engineering group received one (1) sodium chloride mini-bag for evaluation.Visual inspection was performed and the quality engineer was able to not able to (sic) confirm the reported condition.The quality engineer stated that there was no damage or malformations observed with the ports.The batch records pertaining to lot p335133 were reviewed and all applicable process and quality requirements were met.There were no changes to specifications, test methods, process, equipment, or raw material made that contributed to the reported problem.There were no nonconformities, failures, rework or deviations documented that were similar to the reported problem or that could have contributed to the reported problem.

• Brand Name: VIAFLEX
• Type of Device: SET, IV FLUID TRANSFER - VIAFLEX
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; rlt-10; round lake IL 60073
• MDR Report Key: 5789711
• MDR Text Key: 49425834
• Report Number: 5789711
• Device Sequence Number: 1
• Product Code: LHI
• 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: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 2B1307
• Device Catalogue Number: 2B1307
• Device Lot Number: P335133
• Other Device ID Number: 100 ML
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CHEMOTHERAPY