MAUDE Adverse Event Report: COOK INC DOUBLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET; DQY CATHETER, PERCUTANEOUS

Model Number N/A

Device Problems Break (1069); Unraveled Material (1664)

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

Event Date 05/24/2023

Event Type  malfunction  

Manufacturer Narrative

E1 - customer (person): postal code: (b)(6), phone: (b)(6).G4 - pma/510(k) #: preamendment.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

It was reported the wire guide of a double lumen polyurethane central venous catheter set broke prior to use during a right subclavian central line placement for an unknown patient.When the patient was being administered anesthesia, a 5 french central venous catheter set was opened and several defects were noticed.The "puncture dilator" was soft and "not rigid enough" to perform an adequate puncture.The 22 gage needle was missing from the device set.The primary packaging of the wire guide was perforated.In addition, the wire guide broke during manipulation and was not usable.The device set could not be used and was exchanged for another device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.This report captures the broken wire guide.

Manufacturer Narrative

Correction: h6 - annex a 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 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 or that a death or serious injury occurred; nor is it admission 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

Per provided additional information, manipulation of the wire guide was clarified to mean at the time they were passing the wire guide into the patient.The wire guide was reported to have unraveled.

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 unchanged, unknown, or unavailable.Investigation ¿ evaluation an issue regarding the wire guide in a double lumen polyurethane central venous catheter set was reported to cook.While the wire guide was being manipulated into the patient during a right subclavian central line placement, the wire guide unraveled.Another device set was used to complete the procedure.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures for the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.A document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the dhr for the reported lot and records no relevant non-conformances.A review of the sub assembly lots records a relevant non-conformance for bent wire.There are 100% inspections in place to identify this failure before shipping; all non-conforming material was scrapped.A database search for complaints on the reported lot found 3 additional complaints (patient identifiers: 401179, 401181, and 401182) reported from the same customer that occurred during the same event.The additional complaints are not related to the reported failure.Cook also reviewed product labeling.The product ifu, [c_t_ulmbhce_rev8] ¿uncoated and heparin-coated central venous catheters,¿ provides the following information to the user related to the reported failure mode: instructions for use ¿4.Slide safe-t-j wire guide straightener (positioned on distal tip of wire guide) over ¿j¿ portion of wire guide.Pass straightened wire guide through needle;¿ how supplied ¿do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of dmr, ifu, and dhr does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, no device return, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.The customer stated that the device packaging had been perforated upon receiving.It is possible that the wire guide exposure to the elements contributed to the unraveling, but cook is unable to confirm this.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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: DOUBLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
• Type of Device: DQY CATHETER, PERCUTANEOUS
• 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: 17273646
• MDR Text Key: 319059059
• Report Number: 1820334-2023-00872
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2024

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 Model Number: N/A
• Device Catalogue Number: C-UDLM-501J-RSC
• Device Lot Number: 15069506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 09/26/2023; 02/08/2024
• Supplement Dates FDA Received: 10/03/2023; 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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