MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX® EPIDURAL NEEDLE; PERIFIX EPIDURAL NEEDLE

Model Number E2230T

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.(b)(4).One used perifix epidural tuohy needle assembly, with open packaging identifying the reported lot number (00vl494078); and six unused, unopened perifix needles, in packaging identifying the reported lot number, were received for evaluation.Upon visual observation of the used needle sample, the needle cannula was broken off near the hub.The broken off portion of the needle was not returned.Visual examination of the unused needle samples indicated no abnormalities or nonconformances.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or needle material number.There were no other reports of this nature against the reported lot number.The samples and all available information has been forwarded to the device manufacturer of the needle assembly.Their investigation is ongoing at this time.A follow-up report will be filed when the investigation results become available.

Event Description

As reported by the user facility: reports the needle broke off at the hub while performing a transversus abdominis plane (tap) block for a radical prostatectomy procedure.The broken needle fragment migrated to the patient's back and had to be surgically removed.

Manufacturer Narrative

The returned perifix needles were reviewed and inspected by the needle assembly manufacturer.Per the manufacturer's investigation report, the used needle was confirmed to be broken at the hub and the glued part had a crack on the opposite side of the slit.The unused samples were subjected to stiffness testing and dimensional testing according to specification with acceptable results.The manufacturer also reviewed their batch records for the involved needle lots, and there were no abnormalities noted.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.The damage observed on the returned needle appears consistent with the device being subjected to an excessive force which bent and ultimately fractured the needle.If additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: PERIFIX® EPIDURAL NEEDLE
• Type of Device: PERIFIX EPIDURAL NEEDLE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5808135
• MDR Text Key: 49959255
• Report Number: 2523676-2016-00476
• 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,Followup
• Report Date: 06/22/2016

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 Expiration Date: 03/31/2021
• Device Model Number: E2230T
• Device Catalogue Number: 332171
• Device Lot Number: 00VL494078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• 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
• Patient Age: 68 YR