MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. CARESITE® (LAD) SYSTEM; CARESITE SMALL BORE EXTENSION SET

Catalog Number 470100

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample, a thorough sample analysis could not be performed and no specific conclusions can be drawn.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.There were no other reports of this nature against the reported lot number.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by the user facility: reports a patient was in ct with a newly placed, functioning saline lock iv.When contrast was injected, the tubing burst.It did not just become disconnected at the hub of the iv catheter, it actually burst apart.The reporter stated the facility does use the pressure rated t-ports.The pressure was under 300 psi as the machine has a high limit of 300 psi.If the pressure goes over 300 psi the machine will shut off.The reporter also stated that in extreme cases there could be high pressure infiltration to the catheter which could result in necrosis or possible loss of digits.In this case, the patient did bleed.However, there was no patient harm as the iv catheter was still intact and in place.The patient was cleaned up and no other medical intervention was necessary.

• Brand Name: CARESITE® (LAD) SYSTEM
• Type of Device: CARESITE SMALL BORE EXTENSION SET
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR
• Manufacturer Contact: eric roden ; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR ; 5491000
• MDR Report Key: 5416025
• MDR Text Key: 38427605
• Report Number: 9614279-2016-00001
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 470100
• Device Lot Number: 0061460737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• 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