MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CHEMO DISPENSING PINS

Model Number CDP2000

Device Problem Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One used chemo dispensing pin, without packaging, was received for evaluation.The sample was subjected to pressure (leakage) testing according to specification with acceptable results.In an attempt to simulate the reported event, an additional test was performed in which the dispensing pin was spiked into a 100ml glass vial.A syringe filled with water was then connected to the dispensing pin and injected back into the vial.There was no leakage or any push-back of pressure observed when disconnecting the syringe.In addition, the house retain samples of the reported lot number were pulled for evaluation and subjected to the same testing 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 sample 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 # 1: reports that when injecting medication back into the vial, it seems like the vial is pressurized and pushes back on the syringe.On 12/04/2015, additional information was received from the reporting facility indicating there have been 6 - 8 occurrences of chemo leakage due to the pressurization issue experienced.When the syringe was removed from the dispensing pin, there would be some leakage of chemo.The leakage ranged from just a few drops to leakages of around 1 ml.The involved dispensing pins were all from the same lot number, and since changing lot numbers there has been no further problems.

• Brand Name: CHEMO DISPENSING PINS
• Type of Device: CHEMO DISPENSING PIN
• 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: 5311111
• MDR Text Key: 34621487
• Report Number: 2523676-2015-00617
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925401
• 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: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: CDP2000
• Device Catalogue Number: 412014
• Device Lot Number: 0061406170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2014
• 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