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

Catalog Number 4502132

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 (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 france): "needle-damaged-broken." according to the customer: "during spinal anesthesia in an obese patient requiring a 120 mm long pencil point needle.The spinal anesthesia technique was carried out by a doctor as usual, however the needle was broken in two and part of it remained in the patient's back.The caregiver then surgically removed the needle.The patient did not move during the operation.".

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).As no sample and no meaningful picture was provided for investigation a malfunction could not be detected and therefore the complaint is considered as not confirmed.Reviewed the dhr for the batch number 21e27g8218, no abnormality was observed during in-production and final control inspection.Visual inspection for stored same batch needle.Any abnormality was not found.As a result of stiffness test for same batch retention sample, they were met in specification.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: 16930751
• MDR Text Key: 315210396
• Report Number: 9610825-2023-00184
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4502132
• Device Lot Number: 21E27G8218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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