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 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Note: this report is being filed for an item number that is not sold in the united states, however this item or similar items are sold in the united sates by b.Braun medical, inc.We received a used catheter and guide.The vicinity of the tip marking of the catheter was broken.The broken of catheter side was not returned.Investigation result.Visual inspection: the catheter is broken 14mm away from tip.The surface of the catheter had scratched marks.Others: when observing the tearing surface in magnification, it was confirmed that there was a trace like rubbing against something.It is similar to the shape of a reference image we assume a problem during application process.Justification: this complaint is not confirmed.Note: 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 is no serious injury to the patient, so this report has been classified only as a malfunction.The batch record could not be reviewed since the lot number is unknown.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): damaged catheter tip.Staff felt resistance to a catheter when they tried to apply epidural anesthesia.The catheter tip was damaged when they removed it along with a cannula from the patient.There is possibility that fragments still remain in the patient body.

• 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 ; 901 marcon blvd.; allentown 18109 ; 4847197287
• MDR Report Key: 8400416
• MDR Text Key: 140149549
• Report Number: 9610825-2019-00035
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PCK-925J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2019
• Distributor Facility Aware Date: 03/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2019
• Date Manufacturer Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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