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

Catalog Number	4502132-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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 customer: "male patient of 44 years old scheduled by the service of traumatology and orthopedics for surgical washing on september 3, during the anesthetic procedure with the patient in position sims at the moment of the removal of the spinal needle whitacre 27 411/16 this comes out incomplete, radiography is taken ap and lateral lumbosacral column, where image of the rest of the needle in the yellow ligament bent at level l2-l3 is observed.This hospital unit does not have the required infrastructure that's why the patient was send for the next level to have a prompt surgical intervention.Attached image of the needle in question and another normal as reference.They are approximately 2 centimeters of missing needle.".
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.Corrected information d4 primary unique udi number.Additional information d4 expiration date, d9 device returned to manufacturer, h4 device manufacturer date.We received one used pencan 27gx4 3/4" (120mm)-eu/ap/sa without packaging, 1 x-ray image and customer pictures.The following investigations were conducted: visual inspection: the received sample, the x-ray image and the customer pictures were 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 90 mm from the cannula hub.The broken off part was not handed over by the customer.On the received x-ray image parts of the raw cannula (cannula tip) is visible in the skin.The customer pictures shows the used and damaged sample and on one customer picture the broken part is visible inside the skin.Functional inspection: n.A.Physical inspection: afterwards, the outside diameter of the pencan cannula (several areas) was measured according to drawing (pm: 43789).Nominal-value: 0.42 mm +0.01/-0 mm (see drawing).Actual-value: 0.42 - 0.43 mm the measured value (outside diameters) of the pencan cannula is in accordance with the specification.Because the measured value are 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.

• Brand Name: PENCAN®
• Common Device Name: 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: 20345292
• Report Number: 9610825-2024-00735
• Device Sequence Number: 8023937
• Product Code: MIA
• UDI-Device Identifier: 04046964180972
• UDI-Public: (01)04046964180972(11)240112(17)290101(10)24A12H8B04
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 10/31/2024

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: 4502132-13
• Device Lot Number: 24A12H8B04
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male