MAUDE Adverse Event Report: COOK INC COOK TPN SINGLE LUMEN CATHETER REPAIR SET; DQY CATHETER, PERCUTANEOUS

Model Number	G01869
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: not exempt, 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 has been reported that the transparent part of the cook tpn single lumen catheter repair set catheter separated from the hub.No leakage was reported.The device was replaced with another catheter repair kit.No patient harm or adverse effects were reported.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Additional information: d10 ¿ product received on: 27mar2019.Investigation/evaluation: a review of the complaint history, device history record, instructions for use, quality control, as well as a visual inspection of the returned device was conducted during the investigation.One device was returned to for evaluation.Upon visual examination, the glue bond was noted to be broken all the way around the silicone sleeve.Additionally, a document-based investigation evaluation was performed.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.A review of the device history record found zero nonconformances for lot 9016688 that could have contributed to this failure mode.It should be noted that there are no other complaints reported for this lot number.A nonconformance was noted in subassembly lot ic8975663 for ¿glue-inadequate¿ that involved two devices.The manufacturing process performed on these devices during production is an individual process.Since these devices are manufactured one at a time, it is believed that these nonconformance events are not related.A review of the product instructions for use provide no information for end users related to this failure mode.Based on the information provided, examination of returned product and the results of our investigation, a definitive root cause could not be established.Per the quality engineering risk assessment, no further action is required.The appropriate 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 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: COOK TPN SINGLE LUMEN CATHETER REPAIR SET
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8373717
• Report Number: 1820334-2019-00461
• Device Sequence Number: 1332348
• Product Code: DQY
• UDI-Device Identifier: 00827002018693
• UDI-Public: (01)00827002018693(17)191124(10)9016688
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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: 11/24/2019
• Device Model Number: G01869
• Device Catalogue Number: C-RHCS-6.5
• Device Lot Number: 9016688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR