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

Model Number 4502043-13

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

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.We received one (1) used pencan 25gx3 1/2" (88mm) w.Int.-eu/ap/sa without packaging.The following investigations were conducted: visual inspection: the received sample was taken to a visual inspection for damages according to the test method 102002 damages.Definition of the method: damages are visible changes in the original shape or surface of products and packaging caused by mechanical forces and/or manufacturing faults.Nominal: no damage is allowed that endangers the patient, impedes the use of the part as intended (e.G.The impairment of the function of a drop sensor), endangers the assembly or function of the component, impairs the appearance of the component.Actual: the used pencan cannula is broken off 46 mm from the cannula hub.The area of the break from the raw cannula shows that the cannula was bent before the break.Functional inspection: n.A.Physical inspection: afterwards, the outside diameter of the pencan cannula (several areas) was measured according to drawing.Nominal-value: 0.53 mm +0.01/-0 mm actual value: 0.53 mm the measured value (outside diameter) of the pencan cannula is within the specification.Because the measured value is within the specification and the sample was already used, we assume of a problem during the application process.Summary and assessment: based on the conducted investigations the tested sample is within the specification.Therefore, the complaint is considered as not confirmed.

Event Description

According to the customer: "we have had an incident at us linköping where a spinal needle (pencan 25g) broke off inside the patient's back.The needle tip had to be removed through a surgical procedure.The needle is saved and would need to be examined.".

• 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: 18882123
• MDR Text Key: 337860061
• Report Number: 9610825-2024-00172
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 03/11/2024

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: Health Professional
• Device Model Number: 4502043-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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