MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NONVENTED PLUM SET 1'S; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1187912
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is available for investigation.It is yet to be received.
Event or Problem Description
The event involved a plum set that the customer reported an impurity (hair) inside the cassette.The event occurred on an unknown date.No more information was provided.
Additional Manufacturer Narrative
Additional information in sections d10 and g1.H10: received one used list # 118790412, lifeshield latex-free h-p filter prim.I.V.Plumset, conv.Pin 104 inch w/prep inj site & ol; lot # 3864774 on september 26, 2019 for investigation.In regards to the event reported by the customer as hair inside the cassette.A visual inspection of the sample revealed that inside the cassette had a hair; the other components of the sample were reviewed and did not reveal any visual defective condition.Therefore, the sample confirmed the experience code.According to investigation findings, the potential cause is related to personnel.A batch record review revealed no discrepancies that may have contributed to a complaint of this nature.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the final visual, physical evaluation results indicated that the product met specification requirements.

• Brand Name: NONVENTED PLUM SET 1'S
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8842212
• Report Number: 9615050-2019-00310
• Device Sequence Number: 319091
• Product Code: FRN
• UDI-Device Identifier: 10887787009023
• UDI-Public: (01)10887787009023(17)211101(10)3864774
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K982159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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: 11/01/2021
• Device Model Number: 1187912
• Device Catalogue Number: 118790412
• Device Lot Number: 3864774
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 03/01/2020
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1