MAUDE Adverse Event Report: B-BRAUN MEDICAL INC PENCAN; SPINAL TRAY

Catalog Number 333851

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583); Failure to Advance (2524)

Patient Problem Edema (1820)

Event Date 04/04/2015

Event Type  malfunction  

Event Description

Spinal anesthesia was prepared for a severe pre-eclampsia patient with braun, pencan spinal tray, lot: 61397794, exp.Date: 01/2016.All standard asa monitors applied and functional.O2 at 2l nc.Unable to sit up due to severe edematous to lower extremities and buttocks.With patient in rt lateral position and lt leg supported by ob rn staff and lifted up in the air (this is the only way patient feels bearable).Difficult to palpate and identify lumbar interspaces.Hat and mask worn by providers present at time of block.Sterile prep and drape with betadine x3.1% lidocaine local wheal raised at possible l3-4 space.3.5inches pencan needle advanced easy without resistant.Unable to obtain sab access due to needle's length is not long enough.Needle withdrew.Spinal needle broke into 2 pieces which only 2/3 of the needle was removed and other 1/3 length of the needle remained in patient's back tissue.A 2nd attempted via 1 inch above the 1st attempted site using 5 inches pencan needle, advanced easy until + csf.The patient experienced no paresthesias and no heme was present within the csf return.Pf bupivicaine 0.75% 1.6ml with duramorph 200 mcg injected.T4 sensory block obtained.Patient tolerated procedure well.The incident of retaining broken spinal needle informed and explained to patient and boyfriend.Verbalized understand and consented to have dr to do exploration and removal of foreign body from her back after c/s.The c/s procedure went smooth and uneventful.After completion of the c/s, patient was placed on prone position.C arm used to locate and identify the retaining broken needle.Under aseptic condition, dr was able to easily retrieve the foreign body--the broken spinal needle-- through an small incision on patient's back.
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manufacturer response for pencan spinal tray, spinal needle (per site reporter).
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will send it back.

• Brand Name: PENCAN
• Type of Device: SPINAL TRAY
• Manufacturer (Section D): B-BRAUN MEDICAL INC; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 4747365
• MDR Text Key: 16179086
• Report Number: 4747365
• Device Sequence Number: 1
• Product Code: BSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 333851
• Device Lot Number: 61397794
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2015
• Patient Sequence Number: 1