MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PENCAN®; NEEDLE, CONDUCTION, ANESTHETIC

Model Number N/

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received no sample.The following investigations were conducted: visual inspection: n.A.Functional inspection: stiffness test [tm: im-2011, equipment: e-111].Conducted using retention sample for: pencan 25gx4 w.Intro.-eu/ap.Material no.4502116-13xx.Batch no.18g24h8b01.Results: 0.359mm.Specification: max 0.43mm.Span: 10.0mm.Test load: 7n.Physical inspection: n.A.Device history record: no abnormalities found from reviewing the batch records for batch no.18g24h8b01.Summary and assessment: based on the conducted investigations the retention sample(s) are within the specification.Therefore the complaint is considered as not confirmed.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.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 ((b)(4)): needle breakage - anesthesia.Reason for use: spinal anesthesia.Clinical procedure of about 10 minutes for spinal anesthesia.Rupture of needle during attempt for spinal anesthesia with foreign body hold.Consequence: medical intervention.

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).We received: one used pencan 25gx4" (103mm) m.Fk-eu/ap/sa without packaging.Additionally we received one used sterican without packaging.Visual inspection: the returned used sample was subjected to a visual inspection.The pencan cannula is broken off approx.45 mm away from the cannula hub.The structure of the break shows that the pencan cannula was bent before it breaks.The broken off part with the cannula tip was also returned.Physical inspection: in addition, the outside diameter of the pencan cannula was measured according to the drawing.Nominal-value: 0.53 mm +0.01/-0 mm actual-values in several areas: used / damaged sample = 0.53 - 0.54 mm the measured values (outside diameter) of the pencan cannula is within our specification.Summary and assessment: because the measured value is within our specification and the sample was already used, we assume a problem during application process.The tested sample is within our specification.The complaint is not confirmed.

• Brand Name: PENCAN®
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 9218048
• MDR Text Key: 176346022
• Report Number: 9610825-2019-00506
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2023
• Device Model Number: N/
• Device Catalogue Number: 4502116-13
• Device Lot Number: 18G24H8B01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention