MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ANTI-SIPHON VALVE; STOPCOCK, I.V. SET

Catalog Number	B6013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Icu medical received a medwatch uf/importer report #(b)(4).The device has not yet been received.The investigation is pending.
Event or Problem Description
A complaint on an unknown date in june involving an anti-siphon valve experienced leakage.It was reported that the anti-siphon valve was leaking onto the bed.Educator was brought in to assess.Anti-siphon valve was removed.Valve itself looked intact but was leaking.There was a patient involvement and no adverse event.Update 1: the reporter also stated that "i happened to be called into a room when the bedside nurse had noted that an anti-siphon valve on her lipid infusion was leaking.The anti-siphon valve was removed, and i personally attached a saline flush to check and see if it was still leaking and it was.I noticed it was leaking where it was connected to my saline syringe so i removed it and replaced it again also ensuring it was tight so that i could be positive it wasn¿t user error.It continued to leak.The nurse stated that she had not noticed it leaking prior to this.I then removed a new anti-siphon valve from a package and checked that with the saline syringe and there was no leaking.".
Additional Manufacturer Narrative
The complaint of leaks on item b6013 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The device history review (dhr) lot#14017965 was reviewed, and non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: ANTI-SIPHON VALVE
• 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: 20252957
• Report Number: 9617594-2024-01312
• Device Sequence Number: 8637795
• Product Code: FMG
• UDI-Device Identifier: 00887709011038
• UDI-Public: (01)00887709011038(17)290501(10)14017965
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 10/17/2024

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: B6013
• Device Lot Number: 14017965
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• 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: UNSPECIFIED DRUG , MFR UNK
• Patient Sex: Unknown