MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRAY,IRR PISTON SYR, 0.9% STRL SALINE

Catalog Number	DYNC2303
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient used the irrigation piston syringe to perform catheter irrigations.It is unknown how many times the irrigation piston syringe involved in this incident was used for catheter irrigation.It was reported that the patient presented to a local hospital with fever, fatigue, and lethargy.He was diagnosed with a urinary tract infection (uti) and was hospitalized.He reportedly received iv ceftazidime and vancomycin to treat the uti.No additional diagnostic exams/results or medical treatment(s) were reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be identified.Due to the reported hospitalization and need for antibiotic treatment, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the patient experienced a urinary tract infection (uti), was hospitalized, and treated with antibiotics.
Additional Manufacturer Narrative
The manufacturer received five (5) unused samples from the reporting facility.The unused samples were from lot 19cab954, however, the lot number of the irrigation piston syringe and tray involved in the reported incident is unknown.Visual inspection of the samples was performed and it was noted that all seals appeared visually intact.Functional inspection of the seals was performed using blue dye per astm f1929-15 and all seals were found to be intact on all samples received.There were additionally no noted visual defects or abnormalities of the tray components.A root cause for the reported incident was unable to be determined.If additional relevant information becomes available another supplemental medwatch will be filed.

• Common Device Name: TRAY,IRR PISTON SYR, 0.9% STRL SALINE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 9103774
• Report Number: 1417592-2019-00160
• Device Sequence Number: 16837968
• Product Code: PXY
• UDI-Device Identifier: 10080196027682
• UDI-Public: 10080196027682
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DYNC2303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 09/26/2019
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 100 KG