MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERIFIX SOFT TIP; EPIDURAL CATHETER

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received no sample and no picture.The defect is due to a development error and already known.Therefore this complaint is consider as confirmed.A review of the batch and manufacturing records revealed no abnormalities or nonconformities.The complaint is filed for statistical purpose.

Event Description

As reported by the user facility ((b)(4)): connector/catheter-detached.

Manufacturer Narrative

Exemption number e2016018.B.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun melsungen ag internal report # (b)(4).It should be noted that because the initial report was submitted under exemption number e2016018, this follow-up report will also be reported under the exemption number.This follow-up report is being filed to correct the branding and product code sections d1 and d2, as well as to update the result and method codes in section h6 to reflect the design change referenced below.The product design is being updated to increase the force required to open the catheter connector under change control: hc-chc-m-div-1306.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.

• Brand Name: PERIFIX SOFT TIP
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 8712484
• MDR Text Key: 148444741
• Report Number: 9610825-2019-00225
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4512006C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2019
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2019
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1