MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP PCA EXT 80IN WINJECTR-SL; ADMINISTRATION SET

Model Number	1428028
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer indicated that availability of the sample returning is unknown.
Event or Problem Description
The event involved a customer allegation of a ndhep pca ext set 80in that failed at the slide clamp retainer on an unknown date.A loss of fluid as well as blood was visualized by the nurse on the floor, described as minimal.There was patient involvement with adverse event, with unknown delay in critical therapy and unknown need for any medical intervention.
Additional Manufacturer Narrative
Testing and investigation confirmed the reported separation; however, no sample was received for investigation by icu medical.A picture was provided by the customer documenting the reported separation confirming the incident.In the picture there does appear to be solvent on the tubing.However, since the product was not returned for investigation, a comprehensive evaluation cannot be performed to determine the root cause and an evaluation of the solvent that appears to be present could not be conducted.A design/manufacturing review was completed for lot 866825h and no non-conformances were found that would have attributed to the reported complaint.A batch record review was performed to lot# 866825h, list# 142800438 and no discrepancies that may have contributed to a complaint of this nature were found.The quality inspection of final visual and physical evaluation results indicated that the product met specification requirements.Manufacturing quality (mq) performed visual and physical evaluation to 315 and 315 final sets, respectively with zero defects found.Catalog number was updated.

• Brand Name: NDEHP PCA EXT 80IN WINJECTR-SL
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8251108
• Report Number: 9615050-2019-00005
• Device Sequence Number: 1593568
• Product Code: FPA
• UDI-Device Identifier: 10887787005537
• UDI-Public: (01)10887787005537(17)210201(10)866825H
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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: 02/01/2021
• Device Model Number: 1428028
• Device Catalogue Number: 142800438
• Device Lot Number: 866825H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1