MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD 4000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938742

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

Patient Problem No Patient Involvement (2645)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an exactamix eva total parenteral nutrition (tpn) bag had a pinhole along the side seam near the top of the bag which resulted in a leak.This event was discovered during setup and before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed and a small tear in the top left side seam of the bag was observed.A functional leak test identified a leak in the top left side seam of the bag.The reported condition was verified.The cause of the reported condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 4000 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; see h10; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7492358
• MDR Text Key: 107966620
• Report Number: 1416980-2018-02668
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477268
• UDI-Public: (01)00085412477268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: H938742
• Device Lot Number: 1231275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2018
• 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