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

Catalog Number 8445801C

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/30/2017

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.A follow-up report will be submitted when the results of the investigation are available.Note: this report is being filed for the product problem.A second report for the same incident was filed under mfr report number 9610825-2017-00246, for the adverse event.These reports are being filed for the 8445801c catheter component of kit 4514017c.Kit 4514017c is the item that the issue was reported against, however kit 4514017c is not sold in the united states.The catheter component, 8445801c, is used in other perifix one kits that are assembled and sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): catheter-damaged-broken.

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).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.

• 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
• MDR Report Key: 7112566
• MDR Text Key: 94672695
• Report Number: 9610825-2017-00247
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• PMA/PMN Number: K112515
• 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: 01/02/2017,01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8445801C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2017
• Distributor Facility Aware Date: 12/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2017
• Date Manufacturer Received: 11/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1