MAUDE Adverse Event Report: COOK INC UNIVERSA SILICONE FOLEY CATHETER; EZL CATHETER, RETENTION TYPE, BALLOON

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Torn Material (3024)

Patient Problems Swelling (2091); Swollen Glands (2092)

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.

Event Description

It was reported by the user facility that a patient underwent an unspecified procedure using a universa silicone foley catheter.The report indicated that the patient was suffering from haematuria.On (b)(6) 2017 a universa silicone foley catheter was implanted at 10h00 and by 16h00 the catheter was found in the patient¿s bed.The balloon ¿cut in its length¿.Later, at 18h00 a new catheter implanted and by 20h30 the catheter was found in the patient¿s bed once again.The balloon ¿cut in its length¿.Finally, on the morning of (b)(6) 2017 at 05h00 a new universa silicone foley catheter was implanted and the patient¿s bladder was discovered to be swollen.By 08h00 the device was found in the patient¿s bed and the balloon ¿cut in its length¿.No further information was provided, additionally questions have been sent to the customer for clarification.This medwatch is for one out of three universa silicone foley catheter in question, reference mfr 1820334-2017-00847 for this complaint file.The other two remaining universa silicone foley catheter in question; reference: 1820334-2017-00845 and 1820334-2017-00846.

Manufacturer Narrative

(b)(4).Investigation ¿ evaluation: the universa silicone foley catheter was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A documentation review has been performed which included reviews of complaint history, device history records, manufacturing instructions, and quality control.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record showed there were no non-conformances identified during the manufacturing process.A review of complaint history for this product/lot number combination revealed there have been no other complaints received.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: UNIVERSA SILICONE FOLEY CATHETER
• Type of Device: EZL CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6511483
• MDR Text Key: 73374465
• Report Number: 1820334-2017-00847
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00827002532359
• UDI-Public: (01)00827002532359(17)190731(10)7610112
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 033018-CE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: 11/14/2017
• Supplement Dates FDA Received: 12/05/2017
• Date Device Manufactured: 01/23/2017
• 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): Other