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 11/26/2018

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 used in products that are sold in the united states by b.Braun medical, inc.We received: one used catheter and other components.Visual inspection of the catheter: the catheter is broken off 89mm away from the tip.There was a scratch mark on the broken of cross section.The fault could be reconstructed in a test "example of contact and damage of puncture needle and catheter": the catheter was pulled out after pushing the cannula tip while applying a light force so as to cut into the catheter.The broken catheter was reproduce.Visual inspection of the needle tip: there was slight damage.There were no abnormalities such as bending or damage in other parts.Review manufacturing record: we checked our manufacturing records and any abnormality was not found.No abnormality was found in the catheter acceptance inspection result.Justification: the fault could be reconstructed.According to customer, defect was found after operation.So, there was no damage on catheter before use.This complaint was not confirmed.

Event Description

As reported by the user facility ((b)(4)): catheter was broken off.

• 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: 8179348
• MDR Text Key: 131767364
• Report Number: 9610825-2018-00277
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: PCK-626J-1
• Device Lot Number: 18G21H82YH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2018
• Distributor Facility Aware Date: 12/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2018
• Date Manufacturer Received: 11/27/2018
• 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