MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SYRINGE,TOOMEY,IRRIGATION,70CC,STERILE

Catalog Number DYND20323

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer contact that on (b)(6) 2024 during a colonoscopy, the "toomey tip detached in patient".It was reported that due to this, the tip had to be retrieved and "it took an hour to remove it".It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Toomey tip detached in patient.

• Type of Device: SYRINGE,TOOMEY,IRRIGATION,70CC,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18731313
• MDR Text Key: 335722435
• Report Number: 1417592-2024-00076
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYND20323
• Device Lot Number: 0332303A021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2024
• 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
• Patient Outcome(s): Other