MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED TRANSPAC WITH SAFESET; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	UNKNOWN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The event involved a unspecified transpac with safeset where it was reported that the single transducer pressure tubing was connected to an arterial line, when the registered nurse (rn) attempted to draw back on the vamp to draw blood the internal structure of the vamp syringe broke.The tubing was removed from use and a new single transducer set was utilized.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
The reported complaint of plunger tip separation is confirmed on the returned set.During visual inspection, the plunger was found detached from the plunger tip.The plunger tip of the safeset reservoir was separated and unable to be pulled back.The syringe clip was received separated from the safeset reservoir.The probable cause of the detached plunger tip from the plunger is due to the clips not being fully inserted or engaged into the mating component during the manufacturing process in ensenada.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.D9 - date returned to mfg: 4/1/2024.

• Brand Name: UNSPECIFIED TRANSPAC WITH SAFESET
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 19167646
• Report Number: 9617594-2024-00485
• Device Sequence Number: 7330642
• Product Code: DRS
• UDI-Device Identifier: 00887709120778
• UDI-Public: 00887709120778
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• 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): 10/15/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 10/15/2024
• 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: ARTERIAL LINE, UNK MFR
• Patient Sex: Unknown