MAUDE Adverse Event Report: B BRAUN PENCAN SPINAL NEEDLE TRAY 1 UNIT; PENCAN SPINAL TRAY

Model Number P25BK

Device Problem Environmental Compatibility Problem (2929)

Patient Problems Awareness during Anaesthesia (1707); Therapeutic Response, Decreased (2271)

Event Date 01/14/2016

Event Type  malfunction  

Event Description

Anesthesia placed a spinal and it had no effect.C-section was immediately changed from a local to general because of this.Patient reported all feeling/ no numbness.The pencan spinal needle tray was used for spinal anesthesia.Please be aware this same scenario (some with minimal pain relief) has occurred before, usually in the summer.We usually assume this happens because of heat exposure from the transport from warehouse to hospital delivery (to my knowledge the truck is not climate controlled) because we live in (b)(6) and summer heat rises well above 100f for several days/weeks in a row.However, this case happened during our winter month so i thought i would try reporting to your site instead of talking to the mfr.Who never gives me any follow-up.Your input would be greatly appreciated.

• Brand Name: PENCAN SPINAL NEEDLE TRAY 1 UNIT
• Type of Device: PENCAN SPINAL TRAY
• Manufacturer (Section D): B BRAUN; bethleham PA 18018
• MDR Report Key: 5380095
• MDR Text Key: 36478599
• Report Number: MW5059382
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: P25BK
• Device Catalogue Number: 333851
• Device Lot Number: 61454835
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 120