MAUDE Adverse Event Report: COOK INC ONE-PART PERCUTANEOUS ENTRY NEEDLE; DRC TROCAR

Model Number N/A

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Material Protrusion/Extrusion (2979)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

Occupation: unknown.Pma/510(k) #: exempt.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 an unknown patient required a one-part percutaneous entry needle for a picc-line procedure.During the procedure, the needle was difficult to insert through the skin and muscles.The patient experienced pain upon insertion.It was noted the tip of the needle had a "barb." this made it difficult to remove and caused a tear of the vein and a local hemorrhage.Due to this, the operator repeated the puncture on the opposite side of the body.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.D10 ¿ product received on: 13oct2020.It was reported to cook that a one-part percutaneous entry needle had a barb at the end that made the needle difficult to insert and remove from the patient during a picc line procedure.This incident was reported by zkh zeeuws-vlaanderen, in the netherlands.Further communication with the user facility clarified that local hemorrhage occurred and that there was painful entry of the needle through skin and muscles.A review of the complaint history, device history record, and quality control of the device, as well as a visual inspection, were conducted during the investigation.The complainant returned a one-part percutaneous entry needle to cook for investigation.One used needle was received with biomatter present.Inspection found a hook burr at the tip of needle.Additionally, a document based investigation evaluation was performed.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.Product labeling could not be reviewed as this device is not supplied with an instructions for use (ifu).A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot and related subassembly lots records no nonconformances.A data base search revealed no additional complaints for the complaint lot from the field.An additional data base search did not reveal any additional complaints reported for burrs/barbs in the previous year.There is no evidence that there are additional nonconforming devices in house or in the field and this appears to be an isolated incident.Based on the information provided, the examination of returned product and the results of the investigation, it was concluded the main cause of the failure is due to manufacturing and quality control deficiency.The quality control personnel associated with this complaint have been retrained to the appropriate quality control procedure(s).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.

Event Description

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

• Brand Name: ONE-PART PERCUTANEOUS ENTRY NEEDLE
• Type of Device: DRC TROCAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10665210
• MDR Text Key: 215330366
• Report Number: 1820334-2020-01843
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00827002103603
• UDI-Public: (01)00827002103603(17)250311(10)13044911
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SDN-21-5.0-CSV-U
• Device Lot Number: 13044911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other