MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC BAXTER IV FLUID BAGS; CONTAINER, IV

Lot Number Y206375

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Material Puncture/Hole (1504)

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

Event Date 11/17/2016

Event Type  malfunction  

Event Description

Rn was hanging a new fluid bag for nicu patient.The bag was spiked without any problems.The bag was then placed on the iv pole to prime.Once the bag was placed on the iv pole, the spike from the tubing punctured a hole in the iv bag.Pharmacy was notified and a new bag and tubing were obtained for this patient.These bags are relatively new to our organization and they are flimsy.We switched from a different manufacturer to baxter and have had problems with the baxter product.It seems the bags are much more easily punctured vs.The previous manufacturer's product.Pharmacy has also reported issues with these baxter iv bags including leakage with new bags.Manufacturer response for iv bag, baxter iv fluid bags (per site reporter): pharmacy may have been in contact with baxter rep.

• Brand Name: BAXTER IV FLUID BAGS
• Type of Device: CONTAINER, IV
• Manufacturer (Section D): BAXTER INTERNATIONAL INC; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 6208533
• MDR Text Key: 63400770
• Report Number: 6208533
• Device Sequence Number: 1
• Product Code: LXG
• 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: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2017
• Device Lot Number: Y206375
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2016
• 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; NO OTHER THERAPIES