MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SMALL BORE EXTENSION SET

Model Number ET06S

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough sample analysis or batch record review 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 # 2: report the extension sets are leaking at the attachment to the patient connection.In the past month, there were two instances where chemo leaked on the patients arm from the piv extension.The chemo medications used were adriamycin and rituxan, respectively.It was not a large amount that leaked, but a few droplets at a time.The nurse tried reconnecting and tightening the connections, but it still leaked.

• Brand Name: SMALL BORE EXTENSION SET
• Type of Device: SMALL BORE EXTENSION SET
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5402077
• MDR Text Key: 37715714
• Report Number: 2523676-2016-00012
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K760385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/11/2016

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 Model Number: ET06S
• Device Catalogue Number: 471960
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 02/01/2016
• 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