MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PENCAN SPINAL TRAY; PENCAN 25 GA. SPINAL NEEDLE

Model Number P25BK

Device Problems Difficult to Insert (1316); Component Missing (2306)

Patient Problem No Information (3190)

Event Date 08/01/2014

Event Type  Injury  

Event Description

As reported by the user facility: reports the crna experienced difficulty with placing the spinal needle for c-section.The pt was "well defined." the anesthesiologist was not present when the crna attempted to initiate the spinal.Reports it is unk if the crna used the introducer needle provided with the tray.Prior to the procedure, the pt reported that they experienced difficulty once before with a spinal placed in a separate procedure.The anesthesiologist attempted to use the same introducer/spinal needle utilized by the crna and noticed that approximately one inch of the spinal needle was missing.The anesthesiologist was able to palpate the spinal column, confirm placement of the csf with a new needle and perform the block without difficulty.Flat x-ray showed a linear structure projecting superior from the l3 facet on lateral image.The image size measured 1.9 cm.It is undetermined at this time if the pt will have surgery.The facility is currently seeking several opinions.

Manufacturer Narrative

This report has been identified as b braun med inc.Internal report no.(b)(4).The actual device involved in the reported incident was not returned for eval.However, the facility returned a photo depicting the broken needle.The piece that had broken off was not included in the photo.The photo and all available info was forwarded to the device manufacturer (b braun (b)(4)) of the needle.Per the manufacturer's investigation, based on the returned photo, the needle cannula was broken off at the tip.The cannula appeared bent at the point of fracture, however, a definitive conclusion could not be made from the photo.The manufacturer reviewed their batch records for the involved spinal needle lots, and there were no abnormalities or non-conformances of this nature noted during the assembly process or final control inspection.In addition, the retain samples of the involved spinal needle lots were pulled for eval.The cannulas of the retain samples were subjected to a stiffness test according to specification with acceptable results.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or needle material number.There are no other reports of this nature against the reported lot number.Review of the discrepancy mgmt system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature noted during in-process or final product inspection.The event description did indicate it was unknown if the crna used the introducer needle provided with the tray.Without the actual sample, a thorough eval could not be performed and no specific conclusions can be drawn.However, 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.If add'l pertinent info becomes available, a follow-up report will be filed.

• Brand Name: PENCAN SPINAL TRAY
• Type of Device: PENCAN 25 GA. SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 4054123
• MDR Text Key: 18294495
• Report Number: 2523676-2014-00319
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2014

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: 09/30/2014
• Device Model Number: P25BK
• Device Catalogue Number: 333851
• Device Lot Number: 0061304797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2014
• Initial Date FDA Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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
• Patient Age: 19 YR