MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, TRIFURC, ST; SET, I.V. FLUID TRANSFER

Catalog Number H93863

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that holes were observed in the sterile primary packaging of three (3) trifurcated fluid transfer tube sets.This was identified prior to use.There was on patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, h3, h4 and h6.H4: the lot was manufactured from october 23, 2018 - october 24, 2018.H10: three (3) actual samples were received for evaluation.Unaided visual inspection was performed which observed a small hole in the primary packaging of all samples.The reported condition was verified.The cause of the condition was not determined, however, the most likely cause was due to an impact (unknown) causing the small hole in all of the sample packages.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: TUBE SET, STD VOL, TRIFURC, ST
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10825643
• MDR Text Key: 216132035
• Report Number: 1416980-2020-07036
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412476698
• UDI-Public: (01)00085412476698
• Combination Product (y/n): Y
• PMA/PMN Number: K062909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: H93863
• Device Lot Number: 60154303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1