MAUDE Adverse Event Report: COOK INC RADIAL ARTERY PRESSURE MONITORING SET; DQY CATHETER, PERCUTANEOUS

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Surgical procedure, additional (2564); No Code Available (3191)

Event Date 04/20/2015

Event Type  Injury  

Event Description

The left radial arterial line was inserted into a 67 year old female patient on (b)(6) 2015 at 14:00.On (b)(6) 2015 the healing wound looked like it was impregnated with blood.When the bandage was removed the user facility could see that the catheter was broken.The patient required new arterial canalization.

Manufacturer Narrative

(b)(4).This event is currently under investigation.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, quality control and a visual inspection of the returned used device was conducted during the investigation.The visual examination and viewing of the supplied video confirmed a tear in the shaft material, located at the base of the fitting.There is no evidence to suggest that the product was not manufactured to specifications.We are unable to determine the root cause of the failure mode experienced.Per the quality engineering risk assessment (qera) no further risk reduction is required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

The left radial arterial line was inserted into a (b)(6) year old female patient on (b)(6) 2015 at 14:00.On (b)(6) 2015, the healing wound looked like it was impregnated with blood.When the bandage was removed, the user facility could see that the catheter was broken.The patient required new arterial canalization.

• Brand Name: RADIAL ARTERY PRESSURE MONITORING SET
• Type of Device: DQY CATHETER, PERCUTANEOUS
• 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: 4795877
• MDR Text Key: 5858447
• Report Number: 1820334-2015-00251
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: ES
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2017
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-300-RA
• Device Lot Number: 5239277
• Other Device ID Number: (01)00827002019089(17)170826(1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/20/2015
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2014
• 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: 67 YR
• Patient Weight: 90