MAUDE Adverse Event Report: SALTER LABS SALTER LABS; INFUSEIT 500 ML REUSABLE PRESSURE INFUSOR,

Model Number	ZIT-520-5
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the adhesive on the left bag and sleeve peeled off during use which made it impossible to apply pressure.There was no reported injury.
Additional Manufacturer Narrative
The supplier performed an investigation which confirmed the issue as reported; the root cause was determined to be the performance of the nylon material.The supplier has since updated their material performance requirements.The device history record for lot: 230800158 was reviewed and the product was produced according to product specifications.All information reasonably known as of 19 aug 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as complaint: (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.Fda initial mw report submitted on 07may2025; core id: (b)(4).

• Brand Name: SALTER LABS
• Common Device Name: INFUSEIT 500 ML REUSABLE PRESSURE INFUSOR,
• Manufacturer (Section D): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 22845208
• Report Number: 3000219639-2025-00044
• Device Sequence Number: 17355826
• Product Code: KZD
• UDI-Device Identifier: 00607411916915
• UDI-Public: (01)00607411916915(10)230800158(17)280804(11)230804
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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: 230800158
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown