MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PENCAN; SPINAL NEEDLE

Catalog Number 4502051-13

Device Problems Break (1069); Device Handling Problem (3265)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/29/2014

Event Type  Injury  

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): first needle was bent.The anesthesiologist used another needle on an other level.The broken part is left in the muscle of the patient.The neurosurgeon and anesthesiologist looked at the position of the broken needle part and concluded that there is no reason and risk at this moment to remove this part.Mfr # 9610825-2014-00215.

• Brand Name: PENCAN
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen 3421 2; GM 34212
• Manufacturer (Section G): B. BRAUN MEDICAL, INC.; 901 marcon blvd.; allentown PA 18109 934
• Manufacturer Contact: 901 marcon blvd.; allentown, PA 18109-9341
• MDR Report Key: 3896919
• MDR Text Key: 4544983
• Report Number: 2523676-2014-00215
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2014,04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2018
• Device Catalogue Number: 4502051-13
• Device Lot Number: 3L14298B21
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2014
• Distributor Facility Aware Date: 05/06/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other