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

Model Number	ZIT-520-5
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The gauge disconnected from the tubing.
Additional Manufacturer Narrative
Reportable as disconnection happened during use delaying patient therapy.Capa-00463 was initiated for similar complaint.Manufacturing date for lot 20210927 pre-dates the implementation activities of capa-00463.Customer was notified that this complaint, along with several others submitted by the same customer, are tied to capa-00463 and an update would be provided once capa actions are implemented.Customer has not requested additional follow up at this time (reference (b)(4).
Event or Problem Description
The gauge disconnected from the tubing.
Additional Manufacturer Narrative
Reportable as disconnection happened during use delaying patient therapy.(b)(4) was initiated for similar complaint.Manufacturing date for lot 20210927 pre-dates the implementation activities of (b)(4).Customer was notified that this complaint, along with several others submitted by the same customer, are tied to capa-00463 and an update would be provided once capa actions are implemented.Customer has not requested additional follow up at this time (reference complaint-07296) summary: capa-00463 created for this reported failure mode.Manufacturing lot pre-dates capa corrective action implementation.Ra: pressure leaking caused by inadequate or defective materials including gauges is identified in the risk analysis at a 6 (major).

• Brand Name: SALTER LABS
• Common Device Name: 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: 14658263
• Report Number: 3000219639-2022-00026
• Device Sequence Number: 17303097
• Product Code: KZD
• UDI-Device Identifier: 10607411916912
• UDI-Public: 10607411916912
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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 Model Number: ZIT-520-5
• Device Catalogue Number: ZIT-520-5
• Device Lot Number: 20210927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown