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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: patient care manager.Pma/510(k) #: pre-amendment.(b)(4).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 a single lumen polyethylene central venous catheter split/broke following implantation.The device was placed in the user facility's or in the patient's left upper chest without difficulty.The indication for placement was reported to be for prolonged tpn due to gastro issues.The device was secured to the patient using a suture and tegaderm transparent dressing.On (b)(6) 2020, the device failed while the patient was in the nicu.During treatment, leakage was noticed through the dressing, which is when the split in the catheter was discovered.Consequently, an iv was placed.No adverse effects to the patient have been reported.

Event Description

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

Manufacturer Narrative

Investigation / evaluation: it was reported by (b)(6) hospital east that the catheter from a single lumen polyethylene central venous catheter tray (rpn: c-pmsy-301j) split and broke.During treatment, the catheter was observed to be leaking though the dressing and at this time, a split in the catheter was noticed.The catheter was placed on (b)(6) 2020 and failed on (b)(6) 2020.The device was placed in full term female infant for tpn administration due to gastro issues.The catheter was placed in the left upper chest and secured to the patient using tegaderm transparent dressing and sutures.The patient¿s activity level was described as ¿newborn baby, not much activity¿.There was no difficulty during placement that the facility was aware of.A review of the complaint history, instructions for use (ifu), and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One single lumen polyethylene central venous catheter was returned to cook for evaluation.Upon visual inspection, it was noted that the catheter was separated at the end of the hub.A needleless connector with a cap was attached to the hub.Cook has concluded that the device was manufactured to 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 device history record (dhr) was unable to be completed due to a lack lot information for the device.Based on this information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The central venous catheter tray is currently supplied with ifu c_t_ulmbh_rev7.Pdf which provides the following information: ¿intended use: the central venous catheter is designed for treatment of critically ill patients and suggest for: 1.Continuous or intermittent drug infusion.2.Central venous blood pressure monitoring (cvp).3.Acute hyperalimentation.4.Blood sampling.5.Delivery of whole blood or blood products.6.Simultaneous, separate infusion of drugs.Warnings: do not power inject contrast medium through the catheter.Catheter rupture may result.Use of 10ml or larger syringe will reduce the risk of catheter rupture.Left subclavian and left jugular veins should be used only when other sites are not available.Precaution: catheter should not be used for long-term indwelling application¿.Based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause for this event was unable to be established.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: SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10771169
• MDR Text Key: 214147949
• Report Number: 1820334-2020-01990
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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-PMSY-301J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDFUSION MANGUM TUBING.; MEDFUSION MANGUM TUBING