MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. SAFEDAY¿ UNIVERSAL IV SET; IV ADMINISTRATION SET W/ SAFEDAY VALVE

Catalog Number 352894

Device Problems Loose or Intermittent Connection (1371); Chemical Spillage (2894)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by the user facility: event # 8: reports there have been eight recent events where the spinning spiros connector loosened itself (unscrews) off the b.Braun y site.It is anything from enough to cause a leak (chemo spill) to totally coming off.There were no patient injuries.Five of the events occurred with doxorubicin medication; one event occurred with taxotere medication; one event occurred with 5fu medication; and one event occurred with cisplatin medication.

• Brand Name: SAFEDAY¿ UNIVERSAL IV SET
• Type of Device: IV ADMINISTRATION SET W/ SAFEDAY VALVE
• 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: 5144083
• MDR Text Key: 28465962
• Report Number: 9614279-2015-00054
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352894
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2015
• 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