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

Catalog Number 4502132-13

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).We received one used pencan 27gx4 3/4" (120mm)-eu/ap/sa without packaging.The returned sample was taken to a visual inspection for damages according to the test plan.The used pencan cannula is broken off approx.46 mm away from the cannula hub.The structure of the break of the raw cannula shows that the cannula was bent before the break.The broken off part with the cannula tip was also handed over by the customer.In addition, the outside diameter of the pencan cannula (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 diameters) of the pencan cannula is within the specification.As the measured value is within the specification and the sample was already used, we assume of a problem during the application process.A review of the batch and manufacturing records revealed no abnormalities or nonconformities.Functional test of retention sample with same batch: stiffness test.Pencan 27g x 4 3/4 (0.42x120mm)-eu/ap/sa mat.: (b)(4), batch.: 16h23h8b22, result: 0.316mm pass.Test condition: span: 7.5mm, load: 5.5n, standard: max 0.65mm.The complaint is not confirmed.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 broke during spinal anesthesia.The pencan 27gx4 3/4 04x120mm needle broke during spinal anesthesia.The needle broke about 4.5 cm from the needle base and the rest of the needle remained in the patient's body.The needle was surgically removed.Patient weight (b)(6) kg.

• Brand Name: PENCAN
• Type of Device: NEEDLE, CONDUCTION, ANESTH
• 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, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, pa ; 2408332
• MDR Report Key: 10464650
• MDR Text Key: 204711507
• Report Number: 9610825-2020-00195
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2021
• Device Catalogue Number: 4502132-13
• Device Lot Number: 16H23H8B22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2016
• 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
• Patient Weight: 190