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

Catalog Number 8852505

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2022

Event Type  Injury  

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)."the spinal needle has broken in the back of the patient.The tip off the needle had to be removed by a surgeon.".

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).The complaint is under investigation.A follow-up will be provided after the investigation results are available.

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).No sample and no picture has been provided for investigation.No abnormalities have been found in the manufacturing record.Bending stiffness test of the cannula of retention samples reveals the conformity to the specification.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in netherlands."the spinal needle has broken in the back of the patient.The tip off the needle had to be removed by a surgeon.".

• Brand Name: PENCAN®
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14496678
• MDR Text Key: 292701978
• Report Number: 9610825-2022-00197
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8852505
• Device Lot Number: 22B15A8001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention