MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP EXT 8IN MACROB 1Y-CLV-SL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2065428
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is reported to be available for evaluation, however, has yet to be returned.
Event or Problem Description
A medsun mandatory medwatch report (uf/importer # (b)(4)) was received from the user facility stating, ¿¿from staff: rn into to turn patient with another rn.Primary rn checked lines to make sure there was enough slack before turning which there was.When turning the patient, primary rn noticed blood on the bed and found the iv connection tubing to be dislodge from the hub without any tension on the tubing.Epinephrine was running through the tubing at the time, rn quickly switch epinephrine to picc line.Rn notices pressure drop to 99 systolic for a short period of time then bp returned to previous systolic number of 120-130 within an expected timeframe¿ additionally, the customer stated that it is unknown if there were any issues with the set-up/priming because it occurred in the operating room on (b)(6) 2020.The set up was connected to a central line.The rn noticed the breakage when he saw blood on the white sheets and it happened during routine turning.The customer provided a photo and indicated that the break occurred on the tubing near the female adapter.The set was removed and it was not replaced with the same product.No further issues were reported.There was patient involvement, however, there was no report of an adverse event.The event occurred on an unspecified date in (b)(6) 2020.
Additional Manufacturer Narrative
H10 - one used list #206540451, ndehp ext 8in macrob 1y-clv-sl; lot #3907078 was received for evaluation.The set was inspected as received and the tubing was disconnected from the distal luer.There was evidence of insufficient solvent coverage on the disconnected tubing end.The tubing od was measured and found to be within specification.The socket was measured with an iso pin gauge and found to be within specification.The complaint of tubing disconnection can be confirmed.The probable cause of the disconnection is due to insufficient solvent applied at the manufacturing location.The lot history was reviewed and no nonconformities were found which would have contributed to the reported complaint.

• Brand Name: NDEHP EXT 8IN MACROB 1Y-CLV-SL
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 10960942
• Report Number: 9615050-2020-00264
• Device Sequence Number: 3369161
• Product Code: FPA
• UDI-Device Identifier: 10887787005858
• UDI-Public: (01)10887787005858(17)220201(10)3907078
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K151969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

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: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: 2065428
• Device Catalogue Number: 206540451
• Device Lot Number: 3907078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EPINEPHRINE (UNK MFR)
• Patient Age: 60 YR
• Patient Weight: 136