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

Model Number	G03120
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that a single lumen central venous catheter was placed in a patient.The physician attempted to attach an icu medical ¿7¿ small bore pressure infusion ext set w/ microclave and reported air in the line.The physician reported that when a needleless connector was attached to the line with the iv tubing, air was no longer present.No patient harm was reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, drawings, instructions for use, manufacturing instructions, quality control data, and specifications.One catheter was returned to manufacturer for investigation.Function testing determined the catheter aspirated without difficulty.The catheter flushes with ease.Visual exam noted no leaks.A notch in the fitting was noted as per drawing.A review of the device history for lot number 6777438 found there were no non-conformances related to the reported failure mode.A review of complaint history revealed no other complaints associated with the complaint device lot number (6777438).The instructions for use (ifu) provides warnings, product recommendations, contraindications, and intended use information for the device.To conclude, functional tests determined the catheter aspirated and flushed, without issues of leaking.The doctor was concerned the notch in the fitting contributed to the difficulty experienced during use; but the notch is part of the design and the device was found to function correctly in the investigation process.The difficulty the customer experienced could not be recreated in the evaluation.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The complaint was not confirmed based on the investigation of the returned device that concluded the device to be functional as intended.Per the quality engineering risk assessment, no further action is warranted.The appropriate internal personnel have been notified and cook will continue to monitor for similar complaints.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 or Problem Description
No new event information to report.

• Brand Name: SINGLE LUMEN CENTRAL VENOUS CATHETER SET
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8265291
• Report Number: 1820334-2019-00076
• Device Sequence Number: 2100230
• Product Code: DQY
• UDI-Device Identifier: 00827002031203
• UDI-Public: (01)00827002031203(17)190228(10)6777438
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 03/27/2019

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: 02/28/2019
• Device Model Number: G03120
• Device Catalogue Number: C-PUM-301J-PED
• Device Lot Number: 6777438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1