MAUDE Adverse Event Report: COVIDIEN CATH FOLEY SIL ELSTMR 5CC 16FR; CATHETER, UROLOGICAL

Model Number	402716
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported when removing the catheter, the auxiliary nurse withdrew 10ml of the liquid but the catheter did not want to come out, even after irrigation.She then pulled it thinking it was just stuck, but the balloon was full of air.She had to press on the balloon and extract air in order to make it deflate.Additional information received stated there was a complete tear of the urethra (male), hemorrhage, and severe pain.Subsequently hyperthermia and a urinary tract infection.
Additional Manufacturer Narrative
A device history record review could not be completed for the lot number reported as lot number 0178v52qx is not valid.It is assumed that the intended lot number was 0178u52qx.The device history record was reviewed for lot number 0178u52qx and indicated that the product was released accomplishing all quality standards.The product was manufactured between june 26-29, 2020.A physical sample was not received at the manufacturing site for evaluation.However, a photo was provided.The photo was reviewed, and the reported issue was confirmed.Because a physical sample was not received, further investigation of the sample could not be conducted.As a result, the root cause could not be determined.The physical sample is required to define the root cause.If a sample is received at a later date, the investigation will be updated accordingly.All manufactured catheters undergo 100% inspections and any issues that may contribute to a partial balloon deflation, such as foreign particles, stuck thread, raised airlines, and others are rejected and removed from the batch.Rejected catheters are not shipped for commercial use.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: CATH FOLEY SIL ELSTMR 5CC 16FR
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): COVIDIEN; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• MDR Report Key: 12123073
• Report Number: 9611712-2021-00110
• Device Sequence Number: 14656737
• Product Code: KOD
• UDI-Device Identifier: 10884521016163
• UDI-Public: 10884521016163
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: No Information
• Device Model Number: 402716
• Device Catalogue Number: 402716
• Device Lot Number: 0178V52QX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 09/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other