MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CHEMO DISPENSING PIN¿; NEEDLEFREE COLLECTION SYST

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is ongoing at this time.A follow-up report will be submitted when the results of the investigation become available.

Event Description

Stopper displacement occurred when the chemo pen was used with the oncology product, bendeka.Limited information provided.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).As reported by the user facility, it was confirmed that no additional information or samples were available.Without the actual device and/or lot number, a thorough investigation could not be performed.A review of the discrepancy management system (dsms) database was unable to be performed as the lot number was not reported.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: CHEMO DISPENSING PIN¿
• Type of Device: NEEDLEFREE COLLECTION SYST
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 7163627
• MDR Text Key: 96494325
• Report Number: 2523676-2017-00182
• Device Sequence Number: 1
• Product Code: FNY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2017
• 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