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

Catalog Number	H93863
Medical Device Problem Codes	Break (1069); Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing at the junction of the trifurcated and regular tubing on two (2) trifurcated fluid transfer tube sets ¿was breaking off¿ (separated).The issue was identified ¿during set up post spiking three bags just prior to tubing set exiting bsc¿.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H4: the lot was manufactured from july 11, 2018 - july 12, 2018.H10: one (1) actual device was received for evaluation.The remaining sample was not received and therefore, could not be evaluated.Unaided visual inspection was performed and the "y" connector that is connected to the two spike assembly was observed broken.The reported condition was verified.The cause of the condition could not be 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.
Additional Manufacturer Narrative
Correction: b4/f8: date of this report in the initial mdr is being corrected from blank to 07/01/2021.

• Brand Name: TUBE SET, STD VOL, TRIFURC, ST
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12103905
• Report Number: 1416980-2021-04056
• Device Sequence Number: 11811889
• Product Code: FPA
• UDI-Device Identifier: 00085412476698
• UDI-Public: (01)00085412476698
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K062909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2021

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
• Operator of Device: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: H93863
• Device Lot Number: 60137395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/01/2021; 07/21/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 07/29/2021; 08/05/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.