MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. FILTERED EXTENSION SET; FILTERED EXTENSION SET WITH 1.2 MICRON FILTER

Model Number FE1209F

Device Problem Air Leak (1008)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Two used filtered extension sets, without packaging, were received for evaluation.Both sets were received attached to a microbore tubing set.In an attempt to replicate the reported event, the returned sample set-ups (with microbore tubing set still attached) were spiked and primed according to the instructions for use (ifu).There were no air bubbles observed within the filtered extension set tubing line or the microbore tubing set.Furthermore, the sets were subjected to occlusion and air pressure (leakage) testing according to specification with acceptable results.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 or lot number.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned samples met requirements according to specification, and the reported failure could not be reproduced.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: event # 2: reports there have been at least two incidents of air getting in the tubing line below the filter.This is noted in the tubing line where the filter is attached.

• Brand Name: FILTERED EXTENSION SET
• Type of Device: FILTERED EXTENSION SET WITH 1.2 MICRON FILTER
• 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: 5913975
• MDR Text Key: 54267768
• Report Number: 9614279-2016-00054
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: FE1209F
• Device Catalogue Number: 473994
• Device Lot Number: 0061389590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2014
• 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