MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; 1LYR 16FR 10ML 100%SILI UM TRAY

Model Number DYND160816

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/16/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2022 a 16fr silicone foley catheter was placed per physician.Per the facility urine was returned, but the catheter was met with resistance and was unable to insert to bifurcation as per facility training.The foley catheter was removed and a 14fr foley catheter was inserted without difficulty.Per the facility the device is not available to be returned for evaluation.No additional information is available at this time.Due to the reported incident and 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 on (b)(6) 2022 a 16fr silicone foley catheter was placed per physician.Per the facility urine was returned, but the catheter was met with resistance and was unable to insert to bifurcation as per facility training.The foley catheter was removed and a 14fr foley catheter was inserted without difficulty.

• Brand Name: Medline
• Type of Device: 1LYR 16FR 10ML 100%SILI UM TRAY
• 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: 15365063
• MDR Text Key: 299326225
• Report Number: 1417592-2022-00153
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10884389286296
• UDI-Public: 10884389286296
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYND160816
• Device Catalogue Number: DYND160816
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/06/2022
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 88 KG