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 Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone has an extension number (b)(6).The device is available for evaluation-it has not been received.
Event or Problem Description
The event involved a 8" (20 cm) ext set w/1.2 micron filter, clamp, rotating luer where the customer reported that during infusion the total parenteral nutrition (tpn) filter became disconnected from intravenous (iv) tubing spontaneously and could not be reconnected.The customer confirmed with reporter, filter suddenly became disconnected and not secondary to patient agitation.It is unclear how long the tpn infused into patient's bed.A new filter was supplied by pharmacy, and the beside registered nurse (rn) had no trouble connecting filter and resuming infusion.There was patient involvement, no human harm and a delay of therapy as temporary delay infusion had to be paused due to leaking into the bed.A new filter was delivered, applied and infusion was restarted.
Additional Manufacturer Narrative
One (1) 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, and the sample looks like was never used before.Complaint (b)(4) was used as a reference for this complaint, 3 samples with a separation from the outlet filter were received, and the od of the returned samples was measured finding within specification.Complaints of total parental nutrition (tpn) filter broke can be confirmed based on the physically used sample evaluation.The probable cause was due to an insufficient solvent applied during manual process assembly in ensenada.The device history review (dhr) lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.D9 - device available for evaluation: no.

• 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: 20050614
• Report Number: 9617594-2024-01190
• Device Sequence Number: 15427799
• Product Code: FMG
• UDI-Device Identifier: 00887709000087
• UDI-Public: (01)00887709000087(17)281201(10)13847714
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/29/2024

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: 13847714
• 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: 08/23/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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: INTRAVENOUS (IV) TUBING, MFR UNK; TOTAL PARENTERAL NUTRITION (TPN), MFR UNK
• Patient Sex: Unknown