MAUDE Adverse Event Report: 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 08/20/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that (20) trifurcated fluid transfer tube sets had holes in the overpouch.It was further reported that there was no damaged to the shipping carton.This issue was identified during inspection.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufacture date: may 25, 2021 - may 26, 2021.H10: only one (1) actual sample was received for evaluation.Visual inspection using magnification verified damaged primary packaging of a small tear/hole in the back side near the edge of the primary packaging with scuff marks in surrounding area from the inside.The reported condition was verified for the returned samples.The cause of the condition was not determined.However, the possible causes include damage sustained during transport or during customer handling.The remaining nine-teen (19) samples were not received for evaluation; therefore, a device analysis could not be completed.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
• MDR Report Key: 12468117
• MDR Text Key: 271288573
• Report Number: 1416980-2021-05688
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

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: 04/30/2024
• Device Catalogue Number: H93863
• Device Lot Number: 60299273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1