MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX® EPIDURAL ANESTHESIA TRAY

Catalog Number 555076

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough sample analysis or batch record review could not be performed.No specific conclusions could be drawn.While no specific conclusion can be drawn, incidents of this nature can generally occur when the needle is subjected to some type of trauma during use that stresses the device beyond its design capabilities.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or involved needle material number.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports patient underwent placement of continuous labor epidural for planned c-section.The 27 gauge needle attached to the 3cc syringe was used to inject local anesthetic into the skin and subcutaneous tissue, while continuous gentle pressure was applied to the plunger.Upon pulling back on the syringe, without any noticeable resistance, and prior to redirection, the remaining volume of local anesthetic was expelled from the syringe, as it dribbled onto the drape and sterile glove.Upon examining the syringe, the 27 gauge needle had become dislodged from the base.After examining the drape, sterile towel, and immediate vicinity for the needle, the patient was examined and epidural placement proceeded without complication.Through several days of follow up, to include us and plain film, and despite no apparent complaints, discomfort, or unusual symptoms from the patient, a ct of lumbar spine confirmed the dislodged needle was in the patient's lumbar subcutaneous adipose.The needle was then removed under image guidance by the surgery team.

• Brand Name: PERIFIX® EPIDURAL ANESTHESIA TRAY
• Type of Device: EPIDURAL ANESTHESIA TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: bridseida melendez ; 901 marcon blvd; allentown, PA 18109 ; 6102660500
• MDR Report Key: 6067312
• MDR Text Key: 58783620
• Report Number: 2523676-2016-00685
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 555076
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 10/31/2016
• 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): Required Intervention