MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; BAG,DRAINAGE,4L,A/R TOWER,METAL CLAMP

Catalog Number	DYND15405
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Nausea (1970); Pain (1994); Anxiety (2328); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, " from the latter part of (b)(6) of 2024, the nurses were using the bags from the newer medline products.Soon, urine was gushing back into my bladder.I suffered intense bladder spasms, unbearable pain, nausea,fever and ended up with a serious bladder infection.I was getting sicker and weaker by the minute.The problem was the newer bags said they had an anti-reflux feature, so the nurses kept using them but it did not have the feature.I immediately realized that the urine drainage bag did not have the proper anti-reflux valve.My doctor prescribed me a heavy duty antibiotic, ciproflaxin, to fight the nasty bladder infection.I have had pain, suffering, mental anguish, psychological distress, and anxiety when i was so ill".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 or Problem Description
According to the customer, " from the latter part of (b)(6) of 2024, the nurses were using the bags from the newer medline products.Soon, urine was gushing back into my bladder.I suffered intense bladder spasms, unbearable pain, nausea,fever and ended up with a serious bladder infection.".

• Common Device Name: BAG,DRAINAGE,4L,A/R TOWER,METAL CLAMP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19810932
• Report Number: 1417592-2024-00765
• Device Sequence Number: 15327556
• Product Code: KNX
• UDI-Device Identifier: 40080196993407
• UDI-Public: 40080196993407
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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 Catalogue Number: DYND15405
• Device Lot Number: 96922090002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown