MAUDE Adverse Event Report: COOK INC CHAIT PERCUTANEOUS CECOSTOMY CATHETER; KNT TUBES, GASTROINTESTINAL

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

Additional common name/product code: exd irrigator, ostomy.(b)(6).Occupation: perioperative services coordinator.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 there was visible foreign matter inside the primary packaging of a chait percutaneous cecostomy catheter.The foreign matter was described to be a hair trapped within the sterile pouch.No patient contact was made.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: section c, d10 correction: g1, h6- device code investigation - evaluation st george hospital (australia) informed cook that on 21jul2020, they noted a strand of hair in the sealed packaging of a tdcs-100-m (chait percutaneous cecostomy catheter) from lot 10337231.The device did not make patient contact.A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control, as well as an inspection of unused product and a visual inspection of the returned device, was conducted during the investigation.One sealed tdcs-100-m device was returned to cook for evaluation.Upon visual inspection, a dark strand was noted to be free floating within the pouch.Cook has confirmed that the device was manufactured out of specification.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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhr for the reported complaint device lot (10337231) revealed no recorded non-conformances.A database search found no other events associated with the reported device lot.Based on this information, cook has concluded that there is no evidence of non-conforming product from this lot either in house or in field.Cook also reviewed product labeling.The device is packaged with instructions for use [t_tdcs_rev7], which states the following in relation to the reported failure mode: "how supplied supplied sterilized by ethylene oxide gas in peel-open packages.Do not use the product if there is doubt as to whether the product is sterile." based on the information provided, evaluation of the returned product, and the results of the investigation, a definitive root cause for this event has been traced to a deficiency in quality control (manufacturing).The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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: CHAIT PERCUTANEOUS CECOSTOMY CATHETER
• Type of Device: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10308350
• MDR Text Key: 199988602
• Report Number: 1820334-2020-01338
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00827002363922
• UDI-Public: (01)00827002363922(17)230318(10)10337231
• Combination Product (y/n): N
• PMA/PMN Number: K982500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

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: Health Professional
• Device Expiration Date: 03/18/2023
• Device Model Number: N/A
• Device Catalogue Number: TDCS-100-M
• Device Lot Number: 10337231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1