MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; YANKAUER,BULB TIP,W/O VENT,RIGID,STERILE

Catalog Number	DYND50130
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿(b)(6) hospital # (b)(6) received in product for item # dynd50130 and has a slit in the tubing and is not able to use.¿.
Additional Manufacturer Narrative
The reported concern was slit in tubing, and it was reported that the item has a slit in the tubing and is not able to use.Medline quality received 1 cs for evaluation, and a visual and functional inspection was conducted with the provided samples.It was found that the items functioned normally, and there is no slit in the tubing; at this time, the reported concern could not be confirmed, as the samples functioned normally.A retrospective review of the past year indicated that there have been no prior complaints in regard to this issue, and the division will continue to monitor this issue for trending.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: YANKAUER,BULB TIP,W/O VENT,RIGID,STERILE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50787560
• Report Number: 1417592-2026-41999
• Device Sequence Number: 9570436
• Product Code: JOL
• UDI-Device Identifier: 40080196034957
• UDI-Public: 40080196034957
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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
• Device Catalogue Number: DYND50130
• Device Lot Number: 10-48622090001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown