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

Model Number 1187912

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

The sample is available for investigation.It is yet to be received.

Event 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.

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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8842212
• MDR Text Key: 152809993
• Report Number: 9615050-2019-00310
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10887787009023
• UDI-Public: (01)10887787009023(17)211101(10)3864774
• Combination Product (y/n): N
• PMA/PMN Number: K982159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1