MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE¿ CLEA; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	12514-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 7" (18 cm) appx 0.45 ml, pressure infusion (400psig) ext set w/ microclave¿ clear, purple clamp, rotating luer with a possible lot number 13959618.The reported issue involved difficulty in connecting or tightening the connectors of the device, which resulted in leaking from the iv set.Evidence of leaks were observed beneath the tegaderm sticker used to cover the iv and connector.The patient was receiving a ct scan via an apex ct scanner in the emergency room -c pod at the facility.There was patient involvement, but no human harm and no delay in therapy.There were 20 incidents that occurred- this captures the third of 20 reports.
Additional Manufacturer Narrative
The lot number is unknown.However, a possible lot number of 13959618 was provided.- manufacturing date: 01-april-2024 - expiration date: 01-april-2029.The device is not available for investigation.Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
One photo was shared by the customer, where an icu medical set and an unknown bd set are observed, however no anomalies, leaks or damage are observed.The complaint of leaks on item 12514-01 cannot be confirmed.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The device history was reviewed of possible lots number #13959618 was performed and non-conformities were found that would have led to the reported condition on the complaint.Possible lot number involved 1395961; manufactured date 4/1/2024 expiration date 4/1/2029.

• Brand Name: 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE¿ CLEA
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 19905622
• Report Number: 9617594-2024-01056
• Device Sequence Number: 15636390
• Product Code: FPA
• UDI-Device Identifier: 00887709044470
• UDI-Public: 00887709044470
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• 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): 09/02/2024

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: 12514-01
• Device Lot Number: PLOT
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: APEX CT SCANNER, MFR UNK; INSYTE AUTOGUARD, MFR BD; MICROCLAVE¿ (L#12512-01), ICU MEDICAL; TEGADERM, MFR UNK; UNPSECIFIED IV, MFR UNK
• Patient Sex: Unknown