MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; OB PACK

Model Number DYNJ53131B

Device Problem Crack (1135)

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

Event Date 01/20/2021

Event Type  malfunction  

Event Description

It was reported that an ear ulcer syringe component cracked.

Manufacturer Narrative

It was reported that an ear ulcer syringe component cracked.No serious injury or adverse impact to a patient or a user was originally reported.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.A sample was returned for evaluation and it was observed that half of the ear ulcer syringe was open and there was no damage seen to the edge seal of the component.No other physical damage was observed.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on (b)(6) 2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Type of Device: OB PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18984529
• MDR Text Key: 339126750
• Report Number: 1423395-2024-00223
• Device Sequence Number: 1
• Product Code: OKV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ53131B
• Device Lot Number: 20IMC167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other