MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE BULB

Model Number DNSC00943

Device Problem Material Separation (1562)

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

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the bulb of the bulb syringe detaches when the syringe is filled and the bulb is compressed.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.An unused sample was returned for evaluation.Upon inspection of the bulb syringe nothing appeared to be damaged or out of specification.Upon functional testing the device performed as expected and the bulb did not fall off of the syringe when used.The reported problem/issue was unable to be confirmed and a root cause was unable to be determined.Due to the reported problem/issue, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the bulb of the bulb syringe detaches.

• Type of Device: SYRINGE BULB
• 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: 18784803
• MDR Text Key: 337252388
• Report Number: 1423395-2024-00064
• Device Sequence Number: 1
• Product Code: KYZ
• 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: 02/26/2024

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 Model Number: DNSC00943
• Device Lot Number: 19IDC032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 02/26/2024
• 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