MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; C SECTION

Catalog Number DYNJ900794

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

Per the facility the bulb syringe is too stiff.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

Per the facility the bulb syringe is too stiff.

• Type of Device: C SECTION
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19079829
• MDR Text Key: 340684841
• Report Number: 1423395-2024-00284
• Device Sequence Number: 1
• Product Code: OHM
• UDI-Device Identifier: 10888277906600
• UDI-Public: 10888277906600
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2024

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: DYNJ900794
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1