MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. BLOOD SETS WITH CARESITE INJECTION SITES; BLOOD SET W/ FILTER AND HAND PUMP

Catalog Number 354218

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple follow-up attempts with the reporter to obtain additional information were unsuccessful.The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough evaluation could not be performed and no specific conclusions can be drawn.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: event # 1: reports incidents of air in the tubing line once the tubing is primed and blood is being administered.This has occurred four times within a week.The physician was able to draw the air out of the line.There was no patient injury reported.

• Brand Name: BLOOD SETS WITH CARESITE INJECTION SITES
• Type of Device: BLOOD SET W/ FILTER AND HAND PUMP
• 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: 5352312
• MDR Text Key: 35675061
• Report Number: 9614279-2015-00070
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K840212
• 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: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 354218
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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