MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC TRIFURCATED MONITORING KIT W/SAFESET RESERVOIR AND BLOOD SAMPLING PORT; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	426500406
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received.Testing is not complete.
Event or Problem Description
User facility medwatch was received that stated the following: ¿upon pulling a blood sample from the integrated syringe plunger, a specimen was unable to be pulled and blood leaked out behind the syringe plunger and out the plunger hole onto the user¿s hands.The black rubber piece was able to be attached back to the plunger." there was unknown patient involvement, unknown human harm or adverse event, and unknown delay in critical therapy.No additional information received.
Additional Manufacturer Narrative
One (1) used, partial set, transpac trifurcated monitoring kit with safeset reservoir and 2 blood sampling ports, list # 426500406, was received for investigation.The plunger tip of the safeset reservoir was separated and unable to be pulled back.The probable cause was due to the clips not being fully inserted (engaged) into the mating component during the manufacturing process.The reported complaint of the broken plunger was confirmed.The dhr for lot # 3748023 and relevant commodities were reviewed and no non-conformances were noted that would have contributed to the reported complaint.

• Brand Name: TRANSPAC TRIFURCATED MONITORING KIT W/SAFESET RESERVOIR AND BLOOD SAMPLING PORT
• 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
• MDR Report Key: 8170916
• Report Number: 9617594-2018-00225
• Device Sequence Number: 19138956
• Product Code: DRS
• UDI-Device Identifier: 00840619045029
• UDI-Public: (01)00840619045029(17)210701(10)3748023
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: 07/01/2021
• Device Catalogue Number: 426500406
• Device Lot Number: 3748023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1