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

Model Number N/A

Device Problems Difficult to Insert (1316); Component Missing (2306)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report has been identified as b.Braun (b)(4).We received one used perifix catheter out of a perifix-soft-tip 701 set 18g filter lor in open package.The received perifix catheter was taken to a visual examination.The perifix catheter is shorn off approx.9 cm of the catheter tip.The shorn off area is slanted and shows a smooth structure.Additionally the length of the perifix catheter was measured according to drawing.Nominal: 1010 +7.5 -12.5 mm.Actual: 1001 mm.The shorn off part with the catheter tip was not handed over by the customer.Such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off.Please see instructions for use: "never pull the catheter through the needle as it may otherwise shear off." therefore we assume a fault during the application process and consider the complaint as not justified.If additional pertinent information becomes available, a follow up report will be filed.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): epidural: setting up of catheter with a slight difficulty inserting.No difficulty for removal but a part of catheter is missing.A centimeter of catheter in the back intra-muscular patient.

• 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: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5205584
• MDR Text Key: 30568908
• Report Number: 9610825-2015-00510
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2015,10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2020
• Device Model Number: N/A
• Device Catalogue Number: 4510097
• Device Lot Number: 15B06A8701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2015
• Distributor Facility Aware Date: 10/13/2015
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2015
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• 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