MAUDE Adverse Event Report: INTERLINK SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C1103
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient¿s blood was backing up into the filter of a non-dehp extension set, and started to leak from the edge of the filter.The location of the leak was further described as blue and clear plastic part that come together.This was further described by the customer as, ¿the filter has the blue casing and the clear casing and the leaks came from the edge between those casing.No crack noted.¿ this was identified while in use.There was no report of patient injury, or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to e4, f2, g3, h4 and h6.E4: reporter sent to fda: yes (previously no) f2: the user facility submitted a medwatch report for this event: mw5097686 g3: report source: user facility added h10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components are correctly placed and according to specifications.Functional testing including pressure testing and clear passage underwater testing was performed, and it was noted that there was a leak in the filter.The reported condition was verified.The cause of the condition was due to an assembly issue during manufacturing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK SOLUTION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 10909428
• Report Number: 1416980-2020-07403
• Device Sequence Number: 3216923
• Product Code: FPA
• UDI-Device Identifier: 00085412000503
• UDI-Public: (01)00085412000503
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K952074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2021

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 Catalogue Number: 2C1103
• Device Lot Number: R20D30021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/21/2020; 09/15/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 12/28/2020; 09/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2020
• 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: NI.