MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD 250 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938737

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The reported event occurred on an unspecified date in 2016.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an exactamix total parenteral nutrition bag was found leaking from a hole at the bottom of the medication port.This was observed prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection of the returned sample did not identify any abnormalities that could have contributed to the reported condition.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Functional testing was performed and revealed a leak on the front right side of the medication port.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 250 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6321697
• MDR Text Key: 67113079
• Report Number: 1416980-2017-01145
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938737
• Device Lot Number: 1028470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1