MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP CS PRO; GLOVE,EXAM,NITRILE,PF,CSPRO,EXT CUFF, M

Catalog Number	CS16M
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that there are "serious concerns about.Spd gloves.He reported additional glove breakdown, water in gloves and now an employee has an infected finger that they are sending to oc health." it has been determined that though the event did not involve a death or serious injury, recurrence could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.
Event or Problem Description
It was reported that there are "serious concerns about.Spd gloves.He reported additional glove breakdown, water in gloves and now an employee has an infected finger that they are sending to oc health.".

• Brand Name: CS PRO
• Common Device Name: GLOVE,EXAM,NITRILE,PF,CSPRO,EXT CUFF, M
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 25519233
• Report Number: 1417592-2026-02514
• Device Sequence Number: 9993577
• Product Code: LZA
• UDI-Device Identifier: 80888277396394
• UDI-Public: 80888277396394
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K161473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CS16M
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown