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

Catalog Number 4502124-13

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/08/2023

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).The complaint is under investigation.A follow-up will be provided after the investigation 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 Description

As reported by the user facility (translation of user facility information by bbm sales organization in belgium) "needle broke during intervention." according to the customer: "when puncturing with pencan 4502124-13, the needle was found to be too short to reach the spinal space.Upon extracting the needle with the introducer, the doctor felt a click and found about 5 centimetres of the needle missing.A ct lwz was then performed and after neurosurgical advice, it was decided to surgically remove the needle.The piece of broken off needle was delivered to the buying dept.".

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).We received one broken off part of a used pencan 27gx4" (103mm) m.Fk-eu/ap/sa without packaging and two pictures of an optical unused pencan 27gx4" (103mm) m.Fk-eu/ap/sa with packaging.The following investigations were conducted: visual inspection: the sample and the received pictures were taken to a visual inspection for damages according to the test method.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: damages or other deviations were not detected at the sample from the picture.At the received sample we detected that the pencan 27gx4" (103mm) m.Fk-eu/ap/sa is broken off.We only received the segment with the tip.The pencan 27gx4" (103mm) m.Fk-eu/ap/sa is crooked and bent.The area of the break on the raw cannula shows that the cannula was bent before the break.Physical inspection: afterwards, the outside diameter of the pencan 27gx4" (103mm) m.Fk-eu/ap/sa (several areas) was measured according to drawing.Nominal-value: 0.42 mm +0.01/-0 mm.Actual value: 0.42 mm.The measured value (outside diameter) of the pencan 27gx4" (103mm) m.Fk-eu/ap/sa is within the specification.Summary and assessment: because the measured value is within the specification and the sample was already used, we assume of a problem during the handling process.Based on the conducted investigations the tested sample is within the specification.We conducted relevant test for retention sample.Visual: any abnormality was not found.Stiffness test: test method: im-2011, mat:4502124-13xx, batch:22h09h8b05, test spec: max 0.65mm, test result: 0.284mm, judged: within specification, test span:7.5mm, test load:5.5n.Device history record: any abnormality was not found.Conclusion: this complaint was not confirmed.Mat:4502124-13xx.Batch:22h09h8b05.Therefore, the complaint is considered as not confirmed.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.

• Brand Name: PENCAN®
• Type of Device: SPINAL NEEDLE
• 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 ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16761905
• MDR Text Key: 313505580
• Report Number: 9610825-2023-00108
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4502124-13
• Device Lot Number: 22H09H8B05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention