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

Model Number	4502116-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.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.
Event or Problem Description
According to the event description there was an accidental and unpredictable breakage of a spinal needle with retention of its distal end in the subcutis.Reportedly there was an intervention to remove distal part in the subcutis.
Additional 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.Additional information d9 device returned to manufacturer.Visual inspection since the sample of the complaint item was not returned, we confirmed the needle breakage issue from the photo of the complaint item attached to cc/ic notification no.(b)(4).A part of the broken pencan cannula was visible in the photo.There were no abnormalities in the appearance of the retention sample.Functional test result: no abnormality stiffness test of cannula the test result were within the specification.History review result: no abnormality there were no abnormalities in the manufacturing records.Decision and justification this complaint is considered as not confirmed.No abnormalities were found in the investigation results.Material no.: (b)(4).Product name: (b)(4).Batch no.:(b)(4).Bbm investigation report from 2024-11-11.We received one used pencan 25gx4" (103mm) m.Fk-eu/ap/sa in open packaging and 15 samples in original packaging.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: on the cannula that was handed over, the cannula broke off directly at the cannula hub (see picture 4 - 6).Furthermore, the cannula is broken off in the area approximately 53 mm from the cannula hub and strongly kinked in the area approx.46 mm from the cannula hub.The cannula was bent repeatedly at both areas of the fractures and in the area of the kink and this caused the cracks of the cannula.We assume that problems occurred during use, causing the cannula to be bent several times and finally break.At the original packaged samples no damages or other deviations we could detect.Physical inspection: nominal: length of the cannula must be 108,9 ± 0,5 mm according to drawing.Actual: length of the received cannula approx.46 mm and approx.7 mm overall approx.53 mm.This means approx.55,9 mm be missing.This part (approx.55.9 mm from the cannula tip) of the cannula was not handed over by customer.Nominal: outer diameter ø 0,53 mm +0,01 / -0 mm according to drawing.Actual: outer diameter ø 0,53 mm.Summary and assessment: relating to the damaged sample we assume of a problem during the application process.Based on the conducted investigations the tested sample is within the specification.Therefore, the complaint is considered as not confirmed.

• Brand Name: PENCAN®
• Common Device Name: SPINAL ANESTHESIA KIT
• 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: 20591657
• Report Number: 9610825-2024-00785
• Device Sequence Number: 8796793
• Product Code: OFU
• UDI-Device Identifier: 04046964180798
• UDI-Public: (01)04046964180798(11)231120(17)281101(10)23M20H8B02
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4502116-13
• Device Lot Number: 23M20H8B02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Unknown