MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SVS LLC; PREMIERPRO 1000ML PRESSURE INFUSION BAG, MESH BACK

Model Number	8808
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information-investigation conclusion: d4; h2; h6.The product involved in the report has not been returned for evaluation; additionally, no photographic /video evidence was provided.The supplier performed cosmetic and functional inspection on the retained samples; no issues were identified.It was noted that if the stopcock is not turned to a specific position, it may fail to maintain pressure during use.The root cause could not be determined the device history record for lot 240800529 was reviewed and the product was produced according to product specifications.All information reasonably known as of 06 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 (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 mw 1314417-2025-00025_(b)(4) _ submitted to fda on 29apr2025: core id: (b)(4).
Event or Problem Description
It was reported; the bag did not hold pressure during the procedure; there was no reported injury.

• Brand Name: SVS LLC
• Common Device Name: PREMIERPRO 1000ML PRESSURE INFUSION BAG, MESH BACK
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 north ridge dr nw; ste a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 north ridge dr nw; ste a; grand rapids MI 49544
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 22734540
• Report Number: 1314417-2025-00025
• Device Sequence Number: 9120745
• Product Code: KZD
• UDI-Device Identifier: 00818566019653
• UDI-Public: (01)00818566019653(10)240800529(11)240820(17)290820
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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: 8808
• Device Catalogue Number: 8808
• Device Lot Number: 240800529
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown