MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERIFIX®; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number 4456840

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample has been returned for investigation.The batch record could not be reviewed since the lot number is not known.Without the actual sample or lot number, a thorough investigation can not be performed.All available information has been forwarded to the actual manufacturer.If the sample or lot number and/or additional pertinent information becomes available, a follow up report will be filed.Urgent field safety notice: perifix catheter connector reason for the voluntary customer information (field safety notice).The perifix catheter connector is a connection device used by clinicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics.The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.In the course of our regular post market surveillance activities we have found that the perifix catheter connector may not remain closed during use.In some cases this has led to leakage or disconnection of the catheter from the perifix catheter connector.The product design is being updated to increase the force required to open the catheter connector under change control: (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

(b)(4).Disconnection of the catheter despite application of the safety information and rings provided by the laboratory.

• Brand Name: PERIFIX®
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4842408332
• MDR Report Key: 8667111
• MDR Text Key: 147652783
• Report Number: 9610825-2019-00211
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2019

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 Catalogue Number: 4456840
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2019
• Distributor Facility Aware Date: 05/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2019
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/04/2019
• 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: Unknown
• Patient Sequence Number: 1