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

Catalog Number	H93863
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: the event occurred on an unspecified date in (b)(6) 2021, reported as "in the last week." the devices have been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that at least five (5) trifurcated fluid transfer tube sets were breaking during compounding.The event was further described as the tubing does not stick with the normal saline bag and suddenly detached from the bag in the middle of compounding.No cracks were observed.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H4: the lot was manufactured between (b)(6) , 2020 to (b)(6) , 2020.H4: two (2) actual devices were received for evaluation.Unaided eye visual inspection was performed and a detached spike was observed on both samples.Functional testing was not performed for this complaint.The reported condition was verified.The cause of the condition could not be determined; however the most likely cause is due to inadequate or lack of adhesive being applied in the manufacturing process at the base of the spike assemblies causing an incorrect bonding.The remaining three (3) 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12294208
• Report Number: 1416980-2021-04874
• Device Sequence Number: 14235637
• Product Code: FPA
• UDI-Device Identifier: 00085412476698
• UDI-Public: (01)00085412476698
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/09/2021

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: 12/31/2023
• Device Catalogue Number: H93863
• Device Lot Number: 60276002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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