MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, TRIFURC, ST; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number H93863

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a trifurcated fluid transfer tube set had a hole in the packaging.This was identified before use.It was further reported the product was not damaged during the unpacking process.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the device was manufactured from january 06, 2020 - january 12, 2020.H10: the device was received for evaluation.Unaided visual inspection was performed which observed a small hole of approximately 0.01 square millimeters where a puncture occurred in the front side of the primary packaging only in the middle area of the pouch.Additionally observed three (3) sliced areas of the primary packaging in the lower right section in front and back side.The reported condition was verified.The cause of the condition could not be determined.The possible causes of the reported issue of a small hole in the bag include damage sustained during transport and sliced areas of the pouch from a sharp object.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, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11962837
• MDR Text Key: 260152857
• Report Number: 1416980-2021-03467
• Device Sequence Number: 1
• Product Code: FPA
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: H93863
• Device Lot Number: 60276002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1