MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. CUSTOM EPIDURAL ANESTHESIA TRAY; EPIDURAL CATHETER

Catalog Number 555370

Device Problems Patient-Device Incompatibility (2682); Material Integrity Problem (2978)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Reaction (2414); Skin Inflammation (2443)

Event Date 07/26/2014

Event Type  Injury  

Event Description

As reported by the user facility: event #2: reports extreme dermatitis (raised, "beefy red", slightly itchy) at catheter insertion site and along epidural catheter path approximately 1 to 1.5 inches wide.This occurred with two patients.The epidural catheter was placed in t 8-9 for lower abdominal surgery in two patients.Chloraprep was used as skin prep prior to placement of catheters; tegaderm and paper tape was used to secure the epidural catheter in place.The catheters had been in place approximately 3 to 5 days.The area was treated with a local steroid cream.Since there had been no dissipation in redness or condition, a dermatologist consultation was made.During a follow-up call with the reporter, the physician stated that there is no additional info available regarding the incidens or the condition of the patients.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough evaluation could not be performed and no specific conclusions can be drawn.No adverse quality trends of this nature were identified during the complaint review process for the reported tray catalog number, catheter material number, tegaderm material number, or steri-strip tape material number.Chloraprep is not a supplied component contained within the reported tray catalog number.If additional pertinent info becomes available, a follow-up report will be filed.

• Brand Name: CUSTOM EPIDURAL ANESTHESIA TRAY
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 4036784
• MDR Text Key: 4879097
• Report Number: 2523676-2014-00318
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 555370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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