MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SAFESET 84" ARTERIAL PRESSURE TUBING, RESERVOIR, AND 2 NEEDLELESS VALVES; CATHETER, CONTINUOUS FLUSH

Model Number 42322-66

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Investigation is not yet complete.

Event Description

The event involved a safeset 84" arterial pressure tubing, reservoir and 2 needleless valves where it was reported an excessive blood leak at blood draw port, the most distal from safeset syringe.It was mentioned that the staff stated, a central line was connected with an icu medical safeset per protocol.The central line backed up with blood after the system flushed.The connector from sterile field to safeset was checked for tightness.The line re-flushed and blood backed up again.An excessive leaking was noted at the system blood draw port, the most distal from safeset syringe.The system was re-flushed and blood backed up again and was noted with excessive leaking of blood at the same site.The line from patient was clamped, the physician was notified, and the defective safeset was disconnected and removed.The new central line with new safeset was set up and re-connected to patient line per protocol without incident.The leaking no longer occurred.There was a patient involvement and a delay in therapy but no harm.

Manufacturer Narrative

Received one used list #42322-66, safeset¿ 84" arterial pressure tubing, reservoir, and 2 needleless valves; lot #unknown.The reported complaint of leakage was confirmed.During visual inspection, an insertion depth was observed between the female luer of the 12" pressure tubing and the male luer of the 3 way stopcock.This connection is bonded.When the set was primed and pressure leak tested, a leak was observed from the bond site between the female luer of the 12" pressure tubing and the male luer of the 3- way stopcock.The leak had occurred due to the female luer not being fully inserted into the male luer of the stopcock.The probable cause of the leakage had occurred due to the female luer of the 12" pressure tubing not being fully inserted into the male luer of the stopcock during manual assembly.The lot review could not be conducted because there is no lot number provided.

• Brand Name: SAFESET 84" ARTERIAL PRESSURE TUBING, RESERVOIR, AND 2 NEEDLELESS VALVES
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 12244997
• MDR Text Key: 264072447
• Report Number: 9617594-2021-00211
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K932188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42322-66
• Device Catalogue Number: 42322-66
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1