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

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample has been returned for investigation.Without the actual sample (or device), a through investigation could not be performed and no specific conclusion can be drawn as the cause of the reported event.After checking the respective documentation of the production (shift record, results of worker self-inspection and in-process control, machine documentation, cleaning record etc.) no deviations could be identified in the mentioned time period.This report is being filed as both a product problem and an adverse event due to the fact that the tip of the catheter may have remained in the patient.No intervention was done, and currently there was no serious injury to the patient reported, so the report has been classified only as a malfunction.If additional information becomes available, a follow up report will be submitted.

Event Description

As reported by the user facility ((b)(4)): catheter breakage.

• Brand Name: PERIFIX SOFT TIP
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 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: 8500107
• MDR Text Key: 141482763
• Report Number: 9610825-2019-00109
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112515
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2022
• Device Model Number: N/A
• Device Catalogue Number: 4514009
• Device Lot Number: 17C10A8701
• 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: 04/10/2019
• Distributor Facility Aware Date: 04/10/2019
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2019
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2017
• 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
• Patient Outcome(s): Other