MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. IV ADMINISTRATION SET WITH UNIVERSAL SPIKE; GRAVITY IV ADMINISTRATION SET

Catalog Number V1402

Device Problems Crack (1135); Chemical Spillage (2894)

Patient Problems Underdose (2542); Chemical Exposure (2570)

Event Date 03/14/2016

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 that there was a crack at the end tubing and the patient did not receive her full dose of chemotherapy medication (medication was kadcyla).The tubing was not retained and the nurse was unable to determine how much medication the patient received.There was a large spill under the patient's chair.The patient will be coming in the following day to receive the medication.There was no patient injury.

• Brand Name: IV ADMINISTRATION SET WITH UNIVERSAL SPIKE
• Type of Device: GRAVITY IV ADMINISTRATION 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: 5573035
• MDR Text Key: 43277207
• Report Number: 9614279-2016-00013
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150787
• 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: 03/15/2016

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 Expiration Date: 08/31/2018
• Device Catalogue Number: V1402
• Device Lot Number: 0061449226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2015
• 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