MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE,PISTON,IRRIGATION,60ML,STERILE

Catalog Number DYND20325

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

According to the facility the piston syringe does not hold enough suction to remove a clot from the foley catheter.Per the facility the patient's foley was clotted off and required irrigation.Per the facility after multiple attempts the syringe was unable to "hold enough vacuum to remove the clot".Per the facility the foley catheter was removed and replaced.No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility the piston syringe does not hold enough suction to remove a clot from the foley catheter.

• Type of Device: SYRINGE,PISTON,IRRIGATION,60ML,STERILE
• 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: 17905280
• MDR Text Key: 325293837
• Report Number: 1417592-2023-00412
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10080196031863
• UDI-Public: 10080196031863
• 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: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYND20325
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other