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

Catalog Number 560523

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 04/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample, a thorough sample analysis could not be performed and no specific conclusions can be drawn.The event description did indicate that the needle broke while repositioning it.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 additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports the needle broke in the patient during a procedure on (b)(6) 2016.The anesthesiologist placed a sab (subarachnoid block) for a c/section.The needle broke as the anesthesiologist was repositioning it.Approximately 4 cm of the needle remained in the patient.A neurosurgeon was then contacted and an x-ray performed.The x-ray indicated the needle fragment was not in the spinal canal.Another spinal block was administered at the lower lumbar level, and the c/section was then performed without incident.On (b)(6) 2016 the patient underwent surgery to remove the remaining portion of the broken needle fragment.The needle fragment was removed without any complications.

• Brand Name: CUSTOM SPINAL TRAY
• Type of Device: PENCAN® 25 GA. 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: 5657682
• MDR Text Key: 45285471
• Report Number: 2523676-2016-00302
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2016

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: Physician
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 560523
• Device Lot Number: 0061478376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• 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