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

Model Number 4502116N-01

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun internal report number 400637238.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 Description

As reported by the user facility information by bbm sales organization in the united kingdom: "pencan needle snapped during use" according to the complainant: "we had an incident with a bbraun pencan spinal needle snapping in use, with part retained in patient.Its logged as moderate harm, the patient was referred to a neuro surgeon at another hospital for removal and this occurred the day after incident.Therefore the op for total knee replacement was cancelled as no anaesthetic delivered.Spinal needle broke inside patient during attempted spinal anaesthesia.Spinal attempted initially with 88 millimeter (mm) 25 gage (g) needle, no dural tap.Space too deep.Changed to 103 millimeter (mm) needle for 2nd attempt.Felt gritty resistance around 80 millimeter (mm).Removed needle.On removing the needle, spinal needle found to be snapped at around 50 millimeter (mm) length and could feel the rest of needle under the skin.On spine xray, rest on needle lodged between the spinous processes in the interspinous ligament.".

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).1.Visual inspection the complaint sample (one pencan 25gx103mm nrfit w.L.Int.-eu) was returned.When it was received, the broken tip of the cannula was not returned.The protective cap was not returned.The bulk needle cannula broke at around 55mm from the base of the hub.No bends or damage were found on the mandolin.The shape of the broken part was confirmed to be flat and narrow.The shape was very similar to that of the sample that had been intentionally bent and broken.Of the four photos at the bottom of page 2/3 of "y24-0006_investigation result approved", the top two are of returned needles.The two sheets at the bottom are intentionally folded samples.(conclusion) since the broken surfaces of the returned needle and the intentionally broken sample are very similar, the cause of the breaking is thought to be that the cannula was bent many times and subjected to stress.A situation in which the cannula is bent does not occur during the process of manufacturing or transporting the bulk needle.2.Functional test result: no abnormality testing and measuring method no.: im-2011 the test results met our standards.Objects to be measured : pencan bulk nl 0.53 x 103 mat.No.X0211916(retention sample) target batch: 20k03h0b05 standard: max 0.43mm (test condition) iso9626 : 1991 25g/tw span: 10mm, test load: 7n result: 0.299 mm 3.History review result: no abnormality there were no records of defects such as scratches, bends, or breaks on the cannula in the manufacturing records.4.Decision and justification this complaint is considered as not confirmed.The shape of the broken part was confirmed to be flat and narrow.The shape was very similar to that of the sample that had been intentionally bent and broken.Since the broken surfaces of the returned needle and the intentionally broken sample are very similar, the cause of the breaking is thought to be that the cannula was bent many times and subjected to stress during procedure.A situation in which the cannula is bent does not occur during the process of manufacturing or transporting the bulk needle.There were no records of defects such as scratches, bends, or breaks on the cannula in the manufacturing records.From the result of stiffness test for retention sample, the test result met our standards.Complaint sample: stored in the washing room.
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material no.: x0211916 product name: pencan bulk nl 0.53 x 103 batch no.: 20k03h0b05
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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: SPINOCAN®
• 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18662615
• MDR Text Key: 334802003
• Report Number: 9610825-2024-00063
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4502116N-01
• Device Lot Number: 21M30A8701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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
• Patient Outcome(s): Required Intervention