MAUDE Adverse Event Report: SALTER LABS SALTER LABS; INFUSOR,REUSABLE,INFUSEIT 500 ML W/STOPCOCK

Model Number ZIT-520-5

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

The pressure bag leaking pressure could delay or interrupt therapy.This is attached to an arterial line and can impact patient therapy.

Event Description

Infusor leaked air within 10 minutes of beginning use.

Event Description

Infusor leaked air within 10 minutes of beginning use.

Manufacturer Narrative

The pressure bag leaking pressure could delay or interrupt therapy.This is attached to an arterial line and can impact patient therapy.Complaint confirmed by customer's photo of defect.Inventory inspection performed and no non-conformances were identified.The root cause is likely that not enough glue was used.Performed risk assessment and determined a severity rating of 6/10.Sent resolution to the customer.

• Brand Name: SALTER LABS
• Type of Device: INFUSOR,REUSABLE,INFUSEIT 500 ML W/STOPCOCK
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17703794
• MDR Text Key: 323080205
• Report Number: 3000219639-2023-00025
• Device Sequence Number: 1
• Product Code: KZD
• UDI-Device Identifier: 10607411916912
• UDI-Public: 10607411916912
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZIT-520-5
• Device Catalogue Number: ZIT-520-5
• Device Lot Number: 220700780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other