MAUDE Adverse Event Report: COOK INC CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET; JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number G53172

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

Customer (person): phone: (b)(4).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 by a distributer that during inspection, a hole was observed in the packaging of a ciaglia blue rhino percutaneous tracheostomy introducer set.No patient contact was made.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by agility logistics (brazil) that a ciaglia blue rhino percutaneous tracheostomy introducer set (rpn: c-ptis-100-flex-hc-g, lot# 13630837) had hole in the packaging.On 25may2021, the distributor was inspecting product and a hole in the blue rhino packaging was discovered.There was no patient involvement.Reviews of the documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control procedures and specifications of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination was unable to be conducted.However, photos provided by the distributor clearly show a tear near the perforated edge of the packaging.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot 13630837 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with this lot number.Based on the device failure analysis, dhr, and dmr, there is no indication the device was manufactured out of specification.There is no evidence of non-conforming material in house or in the field.Cook also reviewed product labeling.The instructions for use (ifu) c_t_ptisg_rev4 states: upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, examination of photos provided by the distributor and the results of our investigation, it was concluded the likely cause of the failure could be attributed to damage that occurred during transport/storage of the device set.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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.

• Brand Name: CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
• Type of Device: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 11921404
• MDR Text Key: 258605845
• Report Number: 1820334-2021-01439
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 00827002531727
• UDI-Public: (01)00827002531727(17)230801(10)13630837
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/01/2023
• Device Model Number: G53172
• Device Catalogue Number: C-PTIS-100-FLEX-HC-G
• Device Lot Number: 13630837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• 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