MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON F; STOPCOCK, I.V. SET

Catalog Number	B33902
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Separation Failure (2547); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a 13" smallbore quadfuse ext set w/3 microclave® (glow, 2 red rings), 0.2 micron filter, 4 clamps, rotating luer.It was reported that the device had a cracked filter which led to a bad patient outcome requiring unspecified intervention.No specific harm was reported.There is no additional information pertaining to the reported complaint at this time.
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not yet been received.
Event or Problem Description
Updated information from the customer was received on 26-jul-2023 stating that the involved lot number is 13605717 and that the product was used before the issue was noticed.The defective product was infusing with tpn and lipids when leakage occurred several times.The patient generated positive blood culture tests, which required unspecified medical intervention.Although there was a delay in therapy while the tubing was changed out, there was no harm to the patient.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Additional information can be found in b5, b6, d4, d9, d10, h4 and h6.
Additional Manufacturer Narrative
One used sample item #b33902 was returned for evaluation.As received the outlet filter was separated from the rest of the device.No presence of solvent in the tube, neither in the filter port through uv (ultraviolet) light were observed.No additional damage or anomalies were observed along the set.The customer's complaint can be confirmed based on the physical used sample evaluation.As received, the outlet filter was separated from the rest of the device.The probable cause was due to insufficient solvent applied during the manual assembly (manufacturing) process.Updated information from the manufacturer can be found in g1.

• Brand Name: 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON F
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17398377
• Report Number: 9617594-2023-00438
• Device Sequence Number: 7572288
• Product Code: FMG
• UDI-Device Identifier: 00887709071681
• UDI-Public: (01)00887709071681(17)280401(10)13605717
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2023

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 Catalogue Number: B33902
• Device Lot Number: 13605717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 07/26/2023; 10/02/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/15/2023; 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPEC. TOTAL PARENTERAL NUTRITION TPN. MFR UNK.; UNSPECIFIED LIPIDS, MFR UNK.
• Patient Sex: Unknown