MAUDE Adverse Event Report: COOK INC COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 01/12/2017

Event Type  Injury  

Manufacturer Narrative

Common device name) mpb.(b)(4).Pma#) k122091.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

International customer reported that a patient with a previously implanted hemodialysis catheter was being rolled into bed by a nurse and an attending health care associate.All catheter lines were reportedly checked prior to any movement.The patient was then rolled onto her back at which time it was noticed that the hemodialysis catheter came loose of its suture hub and was exiting the insertion site of the patient.The resulting bleeding was controlled by compression at the site.Further inspection by the reporting nurse indicates that the suture hub remained sutured to the patient and the catheter had 'slipped from under the suture plate.' the device did not fracture, accordingly no unintended foreign body was retained within the patient's body.Bleeding was controlled and a new catheter was placed.No further information was provided.

Manufacturer Narrative

Investigation - evaluation: a review of the drawings, instructions for use (ifu), manufacturing instructions and quality control was 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.Based on the information provided, no product returned and the results of our investigation, it is reasonable to suggest that the leading cause of this event may be associated with rough handling of the product during the medical procedure however, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6325304
• MDR Text Key: 67224876
• Report Number: 1820334-2017-00067
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-HDCS-1201J-LSC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 02/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR