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

Catalog Number DYNJ50788F

Device Problems Suction Problem (2170); Detachment of Device or Device Component (2907)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported that a bulb irrigation syringe component broke "apart upon use.".

Manufacturer Narrative

It was reported that a bulb irrigation syringe component broke "apart upon use." 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 testing identified a lack of suction and a small base diameter which would not allow the bulb to properly connect to the syringe barrel.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) 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.

• Type of Device: BREAST 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: 19057220
• MDR Text Key: 339884366
• Report Number: 1423395-2024-00323
• Device Sequence Number: 1
• Product Code: FTN
• UDI-Device Identifier: 40195327421039
• UDI-Public: 40195327421039
• 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: 04/07/2024

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: DYNJ50788F
• Device Lot Number: 23HBI983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other