MAUDE Adverse Event Report: AVAILMED 250 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938737

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

Patient Problem No Patient Involvement (2645)

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 (ethylene vinyl acetate) tpn (total parenteral nutrition) bag was leaking from a pinhole on the tubing near the green clamp.The leak was observed after filling with unspecified medication and prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional leak testing revealed a leak from a tear/hole at the fill port weld area in the back of the bag.The reported condition was verified.The cause of the condition was not 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: 250 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): AVAILMED; tijuana, baja california
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; see h10; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7659365
• MDR Text Key: 113256021
• Report Number: 1416980-2018-04046
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477213
• UDI-Public: (01)00085412477213
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: H938737
• Device Lot Number: 1250830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2018
• 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