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

Model Number P25BK

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

As reported by the user facility: reports incident occurred in ob while inserting a spinal for a c-section.The doctor was observing one of the crna's and when she withdrew the needle it was apparent that the needle was not the same length as when it was inserted.The doctor stated there was not a lot of manipulation or a traumatic insertion of any kind.They proceeded to insert the spinal a few levels up with success, and the c-section went fine.Another doctor was consulted and he had to make an incision to remove the needle fragment.The pt did very well.Follow-up correspondence with the reporting facility indicated the spinal anesthesia was prepared for a severe pre-eclampsia patient.All standard asa monitors applied and functional (o2 at 2l nc).The pt was unable to sit up due to severe edematous to lower extremities and buttocks.The pt was in right lateral position with left leg supported by ob rn staff and lifted up in the air (this was the only way the pt felt bearable).It was difficult to palpate and identify lumbar interspaces.Hat and masks were worn by providers present at time of block.Sterile prep and drape with betadine x 3.1% lidocaine local wheal raised at possible l3-4 space.A 3.5 inches of the pencan needle advanced easy without resistant.Sab access was unable to be obtained due to the needle's length not long enough.The needle was withdrawn.The spinal needle broke into 2 pieces (only 2/3 of the needle was removed and the other 1/3 length of the needle remained in the pt's back tissue).A second attempt was made 1 inch above the first attempted site using a 5 inch pencan needle.The needle advanced easy until csf obtained.The pt experienced no paresthesis, and no heme was present within the csf return.Pf bupivacaine 0.75% 1.6ml with dura morph 200 mcg was injected.T4 sensory block was obtained.The pt tolerated the procedure well.The incident of retaining the broken spinal needle was explained to the pt.The pt verbalized she understood and consented to have the doctor do an exploration and removal of the foreign body from her back after c/s.The c/s procedure went smooth and uneventful.After completion of the c/s, the pt was placed in prone position.C-arm was used to locate and identify the retained broken needle.Under aseptic condition, the doctor was able to easily retrieve the foreign body (the broken spinal needle) through an small incision in the pt's back.

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample, a thorough evaluation could not be performed.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 info has been forwarded to the device manufacturer of the needle.If the physical sample is received or if additional 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: 4740205
• MDR Text Key: 5890535
• Report Number: 2523676-2015-00147
• 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
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: P25BK
• Device Catalogue Number: 333851
• Device Lot Number: 0061397794
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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