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 11/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).We received one catheter.Bbaj investigation result: visual inspection: the catheter has a cut 15mm from the tip.Surface of cut part has a damage which occurred when catheter was pulled from needle.(that is under the ban).Dimensions check: length: 1013mm, the outer diameter: cut part:0.17~1.02mm, damaged part:0.82~0.98mm, no damaged part:1.04mm (unused catheter the outer diameter:1.04mm length:920mm).Tensile strength test it is within the specification: result:8.9n (spec>5n).The occured failure is due to wrong handling by the end user.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): catheter was broken and stay in 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: 6169220
• MDR Text Key: 62209463
• Report Number: 9610825-2016-00893
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2016,11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PCK-469J-2B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2016
• Date Manufacturer Received: 11/17/2016
• 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