MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG PENCAN®; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	4502051-13
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the event description: during a cesarean section using spinal anesthesia, after several attempts, a defect in the spinal needle was noticed (absence of the distal end of the needle, about 4 cm long).
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.Hc-pm complaint processing received no sample, we received one customer picture of the complained and used pencan 27gx3 1/2" (88mm) m.Fk-eu/ap/sa.The following investigations were conducted: visual inspection: the received picture was taken to a visual inspection according 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 received picture shows 3 used pencan 27gx3 1/2" (88mm) m.Fk-eu/ap/sa and a syringe.At the complained and used pencan 27gx3 1/2" (88mm) m.Fk-eu/ap/sa a part of the needle is broken off.The broken off part is not bend.Weak points in the material which lead to a break of the cannula were not detected based on the pictures.At the other two pencan 27gx3 1/2" (88mm) m.Fk-eu/ap/sa no damages were detected.Functional inspection: n.A.Physical inspection: n.A.Summary and assessment: relating to the broken off part of one pencan needle, we assume of a problem during the application process.Therefore, the complaint is considered as not confirmed.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: 1.Visual inspection [confirmation of the complaint symptoms]: because the complaint sample was not returned, we confirmed the complaint from the photo of the product attached to case no.(b)(4).According to the photo, it was confirmed that the pencan 27gx3 1/2 w.Intro.-eu was broken near the center of the effective puncture length.According to the customer information, the break length was 40mm.The cause of the cannula needle's breakage could not be identified from the provided photo.[visual inspection of retention samples]: because the complaint item was not returned, we checked the retention sample of pencan 27gx3 1/2 w.Intro.-eu of the same batch number.There were no abnormalities in the appearance of the retention sample.Ok: 5/5pcs.2.Functional test: result: no abnormality, [stiffness test] (test measurement method im-2011), measured the strength of cannula pipe.Investigation target (retention sample), pencan 27gx3 1/2 w.Intro.-eu, mat.No.4502051-13xx, batch no.23d24h8b01.3.History review: result: no abnormality, there was no record in the manufacturing records of defects such as scratches, bends, or breaks in the canula.4.Decision and justification: this complaint is considered as not confirmed.The investigation into this complaint consisted of a review of the manufacturing records of the bulk needle product in question, a visual inspection of retention samples, and a stiffness test to confirm the strength of the cannula.(results): no abnormalities were found in the manufacturing records.The stiffness test showed no problems with the strength of the cannula.

• Brand Name: PENCAN®
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• 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: 20907110
• Report Number: 9610825-2024-00903
• Device Sequence Number: 21127215
• Product Code: BSP
• UDI-Device Identifier: 04046964180989
• UDI-Public: (01)04046964180989(11)230424(17)280424(10)23D24H8B01
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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
• Report Date (Section B): 12/11/2024

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 Catalogue Number: 4502051-13
• Device Lot Number: 23D24H8B01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Female