MAUDE Adverse Event Report: 8FR REPLOGLE SUCT CATH; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number 8888256529

Device Problems Break (1069); Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported the replogle tube was removed from a patient and found to be fractured, with a small piece of plastic missing from near the end of the tube.The nurse had issues with the tube and found the fracture when it was removed.They are not sure if the piece was fractured before it was inserted but think the nurse would have noticed.Additional information received stated no procedure was done to check for a foreign body in the patient.There is no injury noted at this time.

Manufacturer Narrative

B5 describe event or problem: additional information received from the customer has been added to the description.H6 evaluation code - medical device problem code has been updated from 1069 break to 4039 suction failure per information received from the customer.

Event Description

Additional information received oct.12, 2021: the rn at the facility cut the tube to make the hole larger so the fractured piece of the catheter was intentional and not a break.The rn was unable to get the repolgle to suction/decompress so cut one of the holes larger.

Manufacturer Narrative

H3 evaluation summary: the device history record (dhr) review could not be performed because no lot number was available.One decontaminated sample was received at the manufacturing site.After performing a visual inspection, a damaged tip can be observed.According to the customer's description, the registered nurse at the facility cut the tube to enlarge the hole so that the catheter would suction.Because the sample was tampered with, a bump test cannot be performed, and the condition reported cannot be confirmed.A functional test was not possible to execute at this point.Because a functional inspection is performed during the manufacturing process with acceptable results according to quality standard requirements, the reported failure mode cannot be confirmed to be due to the manufacturing process.The exact root cause could not be determined.The failure mode reported by the customer was not confirmed, no action plan is deemed required.The current process is running according to product specifications, meeting quality acceptance criteria.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: 8FR REPLOGLE SUCT CATH
• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• MDR Report Key: 12512386
• MDR Text Key: 272679808
• Report Number: 9612030-2021-03041
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 10884527006410
• UDI-Public: 10884527006410
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2021

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?: Yes
• Device Operator: No Information
• Device Model Number: 8888256529
• Device Catalogue Number: 8888256529
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 09/13/2021; 09/13/2021
• Supplement Dates FDA Received: 10/13/2021; 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1