MAUDE Adverse Event Report: Medline Industries LP Medline; CVHP DRAWER-SYR TUBING VER.A

Catalog Number	ACC010309A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
"the hospital had a patient code and the physician says that this lactated ringer injection instead of the sodium chloride injection caused them issues and they had to administer antibiotics.".
Additional Manufacturer Narrative
It was reported that "the hospital had a patient code and the physician says that this lactated ringer injection instead of the sodium chloride injection caused them issues and they had to administer antibiotics." however, it was also reported that "the solution is the same, it is the bag that was different".No additional information is available at this time.It has been determined that the reported event caused or contributed to a death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: Medline
• Common Device Name: CVHP DRAWER-SYR TUBING VER.A
• Manufacturer (Section D): Medline Industries LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50102714
• Report Number: 1423395-2026-00459
• Device Sequence Number: 5253041
• Product Code: LRO
• UDI-Device Identifier: 10193489998078
• UDI-Public: 10193489998078
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: ACC010309A
• Device Lot Number: 26BDA403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown