MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.2 ML, 20 DROP ADMIN SET W/INTEGRATED CLAVE DRIP CHAMBER, SPI; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	20124-01
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.Investigation is not yet complete.
Event or Problem Description
The event involved a 30" (76 cm) appx 3.2 ml, 20 drop admin set w/integrated clave® drip chamber, spiros®, bag hanger that the customer reported particulate was found in the set.The customer visualized a piece of what looks like cardboard in the drip chamber that was noticed after attaching a bag prior to adding medication during the line priming step.There was no patient involvement.
Additional Manufacturer Narrative
H10: one (1) used list # 20124-01, 30" (76 cm) appx 3.2 ml, 20 drop admin set w/integrated clave® drip chamber, spiros®, bag hanger; lot # 4949333 --> one (1) used full 25ml container, 0.9% nacl by baxter.The used 20124-01 administration set assembly was returned with a small piece of fibrous material in the drip chamber.The material was extracted from the drip chamber and was analyzed with ft-ir.The result concluded that the fibrous material was not part of any of the components used in the 20124-01 administration set assembly.Though the small piece of fibrous material was confirmed within the drip chamber of the used 20124-01 administration set it is unknown how, when, or where it was introduced into the fluid path of the assembly.The device history review (dhr) for lot number 4949333 was reviewed and there were no relevant non-conformances found.

• Brand Name: 30" (76 CM) APPX 3.2 ML, 20 DROP ADMIN SET W/INTEGRATED CLAVE DRIP CHAMBER, SPI
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 10551026
• Report Number: 9617594-2020-00404
• Device Sequence Number: 2992627
• Product Code: FPA
• UDI-Device Identifier: 00840619023331
• UDI-Public: (01)00840619023331(17)250801(10)4949333
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K070532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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: 08/01/2025
• Device Catalogue Number: 20124-01
• Device Lot Number: 4949333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1