MAUDE Adverse Event Report: COOK INC

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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 a picc line was noted to have split at the catheter entry point to the patient causing chemotherapy drugs to leak/spill.The line was removed and replaced.To date, despite multiple good faith attempts, additional patient, event and device information has not been provided.As reported, the patient did not experience any adverse effects due to this occurrence, however, an additional procedure was required to replace the picc line.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation a review of the documentation, drawing, quality control, and specifications were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.However, by reviewing sales history, investigation was able to narrow down the possible complaint device to one of two products, the turbo-ject® power-injectable picc or the turbo-flo® peripherally inserted central venous catheter.Both devices are shipped with instruction for use (ifu) which note all the proper warnings, precautions, and instruction for use.Additionally, both devices share the same final inspection procedure.This procedure was reviewed and revealed no gaps.Furthermore, the quality control measures for these devices were also reviewed and revealed no gaps.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being initiated to investigate this failure mode.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.

• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7940309
• MDR Text Key: 123065857
• Report Number: 1820334-2018-03041
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• 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?: No
• Date Manufacturer Received: 11/29/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention