MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML IN; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	425880405
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received by the manufacturer for testing.As additional information is received, a supplemental report will be submitted.
Event or Problem Description
It was reported that when the clinician returned to the room, blood had backed up the line to the transducer.The reporter stated, the clinician flushed the catheter which was patent.Then the clinician flushed the line and noticed leaking where the line attaches to the syringe pump which is the short line attached to the pigtail flush device.There was no patient harm reported.No additional information is available.
Additional Manufacturer Narrative
Mfr contact - (b)(4).H10: the reported complaint of leakage and bleed back was confirmed.A leak was observed from the female luer on the proximal end of the set.The female luer attached to the 3" tubing was observed to be cracked.The probable cause of the crack is due to environmental stress on the luer during use.A device history of the reported lot and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: TRANSPAC® IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML IN
• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 8925490
• Report Number: 9617594-2019-00282
• Device Sequence Number: 2128340
• Product Code: DRS
• UDI-Device Identifier: 00840619039585
• UDI-Public: (01)00840619039585(17)220101(10)3944876
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K831506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

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 Expiration Date: 01/01/2022
• Device Catalogue Number: 425880405
• Device Lot Number: 3944876
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1