MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; 1LYR 16FR10ML 100%SIL TMP TRAY

Catalog Number	DYND160816T
Health Effect - Clinical Codes	Abdominal Distention (2601); Vaso-Vagal Response (2661)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a previously draining foley catheter was noted non-draining resulting in patient developing bladder distention and possible vasovagal response.Reportedly, the foley catheter was placed on (b)(6) 2018 at 10:00 pm and was noted draining per patient's input/output record.The patient required the foley catheter for temperature monitoring.It was reported that during insertion, the lubricant from the insertion tray was used.Per report, on (b)(6) 2018 (2 days later), it was discovered that patient's bladder was becoming distended and bladder scan revealed >900 ml urine inside the patient's bladder.The non-draining foley catheter was removed and a new foley catheter was placed with patient's initial urine output of 1300 ml.It was reported that the patient also possibly had a vasovagal response and received unidentified treatment for heart rate and blood pressure.Due to the reported incident and need for medical intervention, this medwatch is being filed.The sample was returned for evaluation and presence of sediment inside the catheter drainage lumen was visualized.Upon flushing, water was able to flow through the drainage lumen of the catheter dislodging some of the sediment.The reported issue of the catheter not draining, related to a product quality issue, was not verified through functional evaluation of the received sample.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a previously draining foley catheter was noted non-draining resulting in patient developing bladder distention and possible vasovagal response.

• Common Device Name: 1LYR 16FR10ML 100%SIL TMP TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7694052
• Report Number: 1417592-2018-00072
• Device Sequence Number: 11042869
• Product Code: OHR
• UDI-Device Identifier: 10884389123119
• UDI-Public: 10884389123119
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYND160816T
• Device Lot Number: 17NB9841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention