MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TAPE,ZINC,PINC,2"X5YD,36/CS

Catalog Number	OMAM222CS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the tape was used during an enema study on a nicu patient to secure the tube in place at the rectum.During the procedure, the tape did not adequately adhere to the infant's skin, resulting in the inability to maintain a proper seal.As a result, leakage of barium occurred from the rectum, compromising the effectiveness of the study.The need to repeat the procedure resulted in additional handling and transport of a critically ill nicu infant.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
The tape used to hold the tube in place in the rectum did not adhere to the skin.

• Common Device Name: TAPE,ZINC,PINC,2"X5YD,36/CS
• 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: 24999800
• Report Number: 1417592-2026-00607
• Device Sequence Number: 9884579
• Product Code: KGX
• UDI-Device Identifier: 10080196035700
• UDI-Public: 10080196035700
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/27/2026

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
• Device Catalogue Number: OMAM222CS
• Device Lot Number: 10080196035700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown