MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1016
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An event involving a 8" (20 cm) ext set w/1.2 micron filter, clamp, rotating luer experienced disconnection.There was a patient involvement, unknown human harm.The initial reporter stated that the customer was notified by bedside that the tpn (total parental nutrition) filter became spontaneously disconnected from the tubing.The customer asked to stop the tpn, disconnected the tubing, and inform the covering service.The customer also provided the bedside rn with the number for the main pharmacy so that a new tpn filter can be sent up.The customer requested that the bedside rn place the broken tpn filter in a biohazard bag, in case pharmacy wishes to examine the product.Second event for the patient, tpn rate was 52 ml/hr.Per documentation infusing via left femoral central triple lumen.Upon inspection of saved broken filter tubing that connects to the patient (female end) disconnected from the filter, patient with restraint orders.
Additional Manufacturer Narrative
D4.And h4.Because lot number is unknown, the expiration and manufacture dates are unknown.E4.The initial reporter phone number was not provided.
Additional Manufacturer Narrative
One photo was shared by the customer, where a tube separation from the inlet filter is observed, no additional damage or anomalies are observed on the photo, the sample look like was never used before.Complaint (b)(4) was used as references for this complaint, 3 samples with a separation from the outlet filter were received, the od of the returned samples were measured finding within specification.Complaint of tpn filter broke can be confirmed based on the physical used sample evaluation.The probable cause was due to an insufficient solvent applied during manual process assembly.The device history lot was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: 8" (20 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER
• 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: 20018184
• Report Number: 9617594-2024-01167
• Device Sequence Number: 7336306
• Product Code: FMG
• UDI-Device Identifier: 00887709000087
• UDI-Public: 00887709000087
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: B1016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: TOTAL PARENTAL NUTRITION, MFR UNK
• Patient Sex: Unknown