MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. SECNDRY SET 34IN NDEHP W/EXT HOOK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1423028

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned to the manufacturer for further evaluation but has not yet been received.

Event Description

It was reported that dark specs were noticed inside the drip chamber.There was no patient involvement reported.No additional information is known at this time.

Event Description

A user facility medwatch was received and was determined to be associated with this event.

Manufacturer Narrative

Date returned to mfr: 8/8/2019.As received, the set was removed from the packaging and visually examined and a spot was identified in the wall of the drip chamber.The combined area of these particles far exceeds the allowable surface area of embedded or attached foreign material per product specifications.The drip chamber was disassembled and the particles were found to be embedded in the drip chamber wall, not in the fluid path.The reported complaint can be confirmed.The most probable cause is burnt material embedded in the wall of the drip chamber during the molding process.The lot history was reviewed and no nonconformances were found that would have contributed to the reported complaint.

• Brand Name: SECNDRY SET 34IN NDEHP W/EXT HOOK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8845659
• MDR Text Key: 152788089
• Report Number: 9615050-2019-00313
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787006268
• UDI-Public: (01)10887787006268(17)220201(10)3894617
• Combination Product (y/n): N
• PMA/PMN Number: K142367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: 1423028
• Device Catalogue Number: 142300490
• Device Lot Number: 3894617
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1