MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PENCAN® SPINAL TRAY; PENCAN SPINAL NEEDLE

Model Number P25BK

Device Problems Bent (1059); Break (1069)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 08/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.However, the facility did return a photo of the involved needle.Based on the photo, the tip of the spinal needle cannula appeared to be broken off.However, without the actual sample, a thorough sample analysis could not be performed and no specific conclusions can be drawn.The event description did indicate that the needle bent during insertion.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.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.All available information has been forwarded to the device manufacturer of the needle.If the physical sample is received or if additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported through medwatch # mw5064185: "anesthesia put needle into spinal column through introducer and the needle bent, approx 2 cms.When the needle was removed from the sheath it appeared as though the sheath cut of the bent portion of the needle and the 2 cm portion of the needle was left in the patient.Imaging was obtained, pt was taken to the operating room, broken needle successfully removed.Diagnosis or reason for use: spinal block." during follow-up correspondence with the facility, the reporter clarified that the needle bent at 2cm and when the surgeon went to remove the needle, it caught on the introducer needle and broke off.

• Brand Name: PENCAN® SPINAL TRAY
• Type of Device: PENCAN SPINAL 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: 5947334
• MDR Text Key: 54625623
• Report Number: 2523676-2016-00594
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2017
• Device Model Number: P25BK
• Device Catalogue Number: 333851
• Device Lot Number: 0061493108
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2016
• 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