MAUDE Adverse Event Report: COOK INC UNKNOWN

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

Common name & product code: unavailable as the device lot number, rpn, and gpn are unknown.Occupation: clinical product evaluation coordinator.Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown.(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 fracture occurred in the blue hub of a central line device.The device name is currently unknown.The physician ordered a nicardipine drip to be discontinued.When the nicardipine drip was discontinued, the line was assessed for blood return.The line was then flushed with normal saline.While the line was being flushed with normal saline, the saline escaped the device around the central line hub and needleless connector.The needleless connector was removed and replaced.The device was flushed again with normal saline.Normal saline did not escape the line but escaped around the needleless connector.The needleless connector was removed and a fracture was noted in the blue hub of the central line.The physician and nurse practitioner were notified of the issue with the line.The patient's mother was informed that the line was not functioning as intended and should be removed.The device as removed, and the vascular access team was called to plan a peripheral intravenous line.The device with the cracked hub was "placed in biohazard bag for cns." additional information regarding event details and patient outcome have been requested, but have not been provided at this time.

Manufacturer Narrative

Additional information: d10 ¿ product received on 18apr2019.Investigation - evaluation: a review of the instructions for use, manufacturing instructions, and quality control, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One 5 fr double lumen catheter was returned for evaluation.The catheter was not abrm coated.One needleless connector was attached to the white hub (lumen #1).One normal saline single use injection syringe was attached to the blue hub (lumen #2).Biomatter was observed on the suture manifold, within both extension tubes and appeared to be occluding the extension tubes.Kinks were observed where the blue clamps attach to the extension tubes.There was no damage observed on the white hub.A slight blue-green discoloration was noted on the luer lock, and this discoloration was also consistent on the needleless connector attached.A crack was found on the blue hub 11cm from the luer lock end.The crack was parallel with the wing, opposite the side of the gate.No additional damage was noted on the blue hub.A leak test was performed on both hubs using a 20cc syringe.After slight resistance was initially felt, the white hub was successfully flushed with no leaks identified.This resistance was likely due to biomatter within the extension tube.Both biomatter and water exited the distal lumen.After attempting to flush the blue hub, water was found to be leaking through the hub crack additionally, a document-based investigation evaluation was performed.It was concluded that there are sufficient inspection activities in place to identify this failure mode prior to distribution.A review of the device history record could not be completed, as the lot information is unknown.As adequate inspection activities have been established, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: "do not re-sterilize catheter.Do not cut, trim or modify catheter or components prior to placement or intraoperatively." how supplied: "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." the investigation found that the affected component was supplied to cook by a supplier.A supplier investigation was not requested, as the exact lot and oem part # were unknown based on the lack of information available.However, a supplier investigation involving a similar product and similar event was referenced.Per pr244950 (medwatch report # 1820334-2018-03088), the supplier reviewed manufacturing logs of hub lots.No anomalies were noted in the manufacturing process, and parameters were within validated manufacturing specifications.No evidence exists to assume parts do not meet specifications.Inspections performed during manufacturing yielded no parts out of specification.The supplier stated that there was no known relationship of the device to the reported event.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a definitive root cause could not be established.Appropriate measures are being taken to address this failure mode.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified and we 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.

Event Description

No new event description information to report at this time.

Event Description

In additional information received on 18mar2019, the patient required a peripheral iv to be placed.The central line was used for long term need of fluids/medications.The customer is unsure when device was originally placed.

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 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: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8433282
• MDR Text Key: 139246404
• Report Number: 1820334-2019-00679
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention