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

Model Number 4502051-13

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/12/2024

Event Type  Injury  

Event Description

According to the customer: "needle breaks." "device fragmentation during placement.The user had to intervene the patient to take out the broken part.".

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.Hc-pm complaint processing received no sample and no picture.The following investigations were conducted: visual inspection: no sample was received and thus a further evaluation and investigation of the complaint is not possible.Functional inspection: n.A.Physical inspection: n.A.Summary and assessment: as no sample and no picture was provided for investigation a malfunction could not be detected and therefore the complaint is considered as not confirmed.The complaint is only taken to knowledge and filed for statistical purposes.However, if the complaint sample will be provided, the complaint will be re-opened accordingly.The investigation sample(s) is/are not available.Bbaj investigation result approved.1.Visual inspection: [visual inspection of retention sample].Any abnormality was not observed on the appearance of retention samples(5pcs was observed).2.Functional test: result: no abnormality.

• Brand Name: PENCAN®
• Type of Device: SPINAL ANESTHESIA
• 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18897484
• MDR Text Key: 337590070
• Report Number: 9610825-2024-00178
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4502051-13
• Device Lot Number: 23D24H8B01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/24/2023
• 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