MAUDE Adverse Event Report: 2565 REPLOGLE CATH 10 FR; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	8888256503
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that when inserting a 10fr argyle replogle suction catheter, they met resistance and pulled the tube back out.The rounded fenestrated end of the tube appeared to be sheared off right where the holes would normally begin.The customer notified the medical team that there was a chance the remainder of the tube was broken off inside the patient.The medical team ordered an x-ray to see if they could locate the foreign body as the product is radiopaque.They were unable to locate any sign of a foreign body so they assume the tube was defective from the manufacture.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was manufactured on june 26, 2019 and released accomplishing all quality standards.One decontaminated sample with lot number 1916945464 was received at the manufacturing site on january 08, 2021.A visual inspection was performed per procedure and the reported issue was confirmed, the tube was observed to be cut due to being trapped in the seal.During the investigation, a review of the manufacturing process was conducted.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging and inspections performed to the product.The process was running according to approved specifications.Based on the investigation performed by the multifunctional team, it was concluded that the most likely root cause is due to a workmanship issue, as during the process the operator did not confirm placing the part inside the cavity and the packer did not make sure that the component was acceptable.The failure mode was evaluated against the acceptable quality limit (aql), and no action plan is deemed required since the complaint reported represents a defect rate of (b)(4), which is below the approved aql of (b)(4).In addition, there have been no trends identified indicating a potential issue with the manufacturing process.This incident is considered to be an isolated event.A production notification was issued to all involved personnel to ensure that they are aware of the condition reported.The current process is running according to product specifications meeting quality acceptance criteria.We will continue to monitor the process for any adverse trends that require immediate attention.

• Brand Name: 2565 REPLOGLE CATH 10 FR
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• MDR Report Key: 11015880
• Report Number: 9612030-2020-02719
• Device Sequence Number: 4241422
• Product Code: BSY
• UDI-Device Identifier: 20884521102443
• UDI-Public: 20884521102443
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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
• Operator of Device: No Information
• Device Model Number: 8888256503
• Device Catalogue Number: 8888256503
• Device Lot Number: 1916945464
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/05/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 17 DA