MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX®; CATHETER, CONDUCTION, ANES

Catalog Number 333540

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as event fifteen of b.Braun medical inc.Internal report # (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.However, due to this complaint and other confirmed complaints of this nature, b.Braun medical has initiated a corrective action/ preventative action (capa) (b)(4) to address the issue of sheared/damaged catheters.If additional pertinent information becomes available a follow-up report will be filed.Note: this case is being filed retrospectively as a result of a review of recent customer complaint information.Based on additional information and details provided in another complaint case, it was determined that this case is reportable in accordance with the requirements of 21 cfr 803.B.Braun has conducted a retrospective review for all complaints of a similar nature in accordance with internal procedure (b)(4).

Event Description

As reported by user facility: event 15.While removing a catheter it broke.No patient injury.

• Brand Name: PERIFIX®
• Type of Device: CATHETER, CONDUCTION, ANES
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: bridseida melendez ; 901 marcon blvd; allentown, PA 18109 ; 6102660500
• MDR Report Key: 6134582
• MDR Text Key: 61250283
• Report Number: 2523676-2016-00873
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 333540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2015
• 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