MAUDE Adverse Event Report: COOK INC FROVA INTUBATING INTRODUCER; LRC CHANGER, TUBE, ENDOTRACHEAL

Model Number N/A

Device Problem Break (1069)

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

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510(k) #: exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that an unknown quantity of frova intubating introducers from the same lot broke as they were bent.No patient contact was made.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction- the summary report designation is incorrect; the report is not a summary report.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

D10 ¿ product received on: 01apr2021.Investigation ¿ evaluation: it was reported by mr.Ma immaduddin from hospital sultan abdul halim that a frova fr 8.0 was easily broken when bent.When testing another frova (from another batch), it was not broken when bent similarly.A review of the documentation including the instructions for use (ifu) and quality control, as well as a visual inspection of the returned device was conducted during the investigation.The customer returned one device for evaluation without packaging.The returned complaint device confirmed the customers report the device was broken into 19 different segments.The edges of sections appear to be jagged.Additionally, a document based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history and search for additional complaints on the same lot could not be carried out as the lot number is unknown.The instructions for use (ifu) contains the following relevant information: the air exchange catheter is currently supplied with ifu c_t_cae_rev6.Pdf which includes the following intended use the cook airway exchange catheter is intended for uncomplicated, atraumatic endotracheal tube exchange.Warnings -attention should be paid to insertion depth of the catheter into patient`s airway and correct tracheal position of replacement endotracheal tube.Catheter and endotracheal tube should not be advanced beyond the carina.-ensure proper sizing of the cook airway exchange catheter within a double-lumen endotracheal tube.Failure to do so may cause small fragments to be shave off during removal of the cook airway exchange catheter.Precautions.¿.Standard techniques for placement and exchange of endotracheal tube should be employed.Endotracheal tube exchange 7.Remove the cae catheter and inflate the balloon cuff of the new endotracheal tube.Confirm its position using standard methods (e.G.Capnography, breath sounds and chest x-ray) the evidence from the complaint file and quality control documents indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.Based on the information provided, inspection of returned product and the results of the investigation, a definitive cause could not be established.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FROVA INTUBATING INTRODUCER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11414434
• MDR Text Key: 238666039
• Report Number: 1820334-2021-00883
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-8.0-35-FII
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1