MAUDE Adverse Event Report: AVAILMED 3000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938741

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

Patient Problem No Patient Involvement (2645)

Event Date 08/24/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During compounding, a hole was observed in an exactamix 3000 ml eva tpn bag during compounding.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The lot was manufactured between february 02, 2018 ¿ february 03, 2018.The device was received for evaluation.Visual inspection on the returned sample revealed a hole/puncture at the back of the bag.No functional testing was performed as reported condition was verified during initial inspection.The cause of the condition could not be determined.This issue is being further investigated.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: 3000 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; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8124974
• MDR Text Key: 129056195
• Report Number: 1416980-2018-07563
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477251
• UDI-Public: (01)00085412477251
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

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: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: H938741
• Device Lot Number: 60110506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/26/2018
• Supplement Dates FDA Received: 12/28/2018
• 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