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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: not exempt, pre-amendment.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a patient underwent an unknown procedure in which a triple lumen polyurethane central venous catheter tray was used.When the central line of the catheter was placed, the spring component of the wire guide broke as it was pulled out of the catheter.It was reported that "the guide wire was placed through insertion needle with no issues," but resistance was felt when removing the guide wire from the central line catheter."anesthesia pulled guide wire back and had resistance and had to remove everything." as reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.A review of the documentation including the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi) and quality control, as well as a visual inspection and dimensional verification of the returned device was conducted during the investigation.One used wire and cvc device were returned to cook for investigation.Upon physical examination, slight biomatter was noted throughout the device.Elongation was found near the distal tip.No other damage was noted.Both weld balls were intact.At this time, there is no evidence suggesting that the device was manufactured out of specification.Additionally, a document-based investigation evaluation was completed.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.A review of the dhrs for the complaint device lot (9785414) and associated wire guide component lot (ic9688885) revealed no non-conformances.A database search found no additional complaints associated with the provided complaint lot.Furthermore, there is no evidence to suggest that non-conforming product from this lot exists either in house or in field.Cook also reviewed product labeling.The product ifu provides the following information to the user related to the reported failure mode: instructions for use: ¿2.Prepare the catheter for insertion by flushing each of the lumens and clamping or attaching the injection caps to the appropriate extensions.Leave the distal extension uncapped for wire guide passage.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; advance wire guide 5-10 cm into vessel.If straight wire is used, always advance soft, flexible end through needle hub and into vessel.If resistance is encountered during wire guide insertion, do not force wire guide.Withdrawal of wire guide through needle should be avoided; breakage may result.5.While maintaining wire guide position, withdraw needle and safe-t-j wire guide straightener.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.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.¿ based on the information provided, inspection of the returned product, and the results of our investigation, a definitive root cause could not be established.It is possible that manipulation of the wire through an insertion needle could have caused the damage to the wire, but this cannot be confirmed due to missing information.It was concluded that a component failure without a manufacturing or design issue contributed to the failure mode.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.The appropriate personnel will be notified.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 or Problem Description
No additional information has been received regarding patient and/or event details since the previous medwatch report was sent.
Additional Manufacturer Narrative
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.

• Brand Name: TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER TRAY
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8959775
• Report Number: 1820334-2019-02210
• Device Sequence Number: 16748370
• Product Code: DQY
• UDI-Device Identifier: 00827002269415
• UDI-Public: (01)00827002269415(17)210712(10)9785414
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2019

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: Health Professional
• Device Expiration Date: 07/12/2021
• Device Model Number: N/A
• Device Catalogue Number: C-UTLMY-501J-CCT
• Device Lot Number: 9785414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/15/2019; 12/06/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 11/13/2019; 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1