MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,COUDE,LATEX,16FR,10ML

Catalog Number DYND11216

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Local Reaction (2035)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the silicone-elastomer coated latex foley catheter was placed in patient's laparoscopic-assisted diverting loop ileostomy to drain the patient's bowel and to keep the ileostomy open.Reportedly, it was known before foley catheter insertion that patient is allergic to latex; however, it was not noted prior to insertion into patient that the foley catheter is made with natural rubber latex.Approximately six days after the latex foley catheter was inserted into patient, the patient's diverting loop ileostomy was noted sloughing and with fibrino-purulent exudate present.Per report, patient required surgery to debride the ileostomy.It was added that an allergy physician consult was obtained and the ostomy care was managed by wound care services.The patient was reportedly discharged from the facility in stable condition with healthy-appearing stoma.Due to the reported event and required ileostomy debridement, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause for the reported issue is unintended user error/misuse.Information for use indicate: "silicone elastomer coated latex foley catheter", "for urological use only", "caution: this product contains natural rubber latex which may cause allergic reactions." no additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that a latex foley catheter was inserted into the ileostomy of a patient(with known latex allergy).The ileostomy developed sloughing and required surgical debridement.

• Type of Device: CATHETER,FOLEY,COUDE,LATEX,16FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8753492
• MDR Text Key: 149804311
• Report Number: 1417592-2019-00107
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10080196726769
• UDI-Public: 10080196726769
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/02/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: DYND11216
• Device Lot Number: 59218050434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 80