MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PENCAN; NEEDLE, SPINAL, SHORT TERM

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

(b)(4).We received: one used pencan 27gx88mm nrfit m.N-l.Int.-eu without packaging.The returned sample was subjected to a visual examination.The pencan cannula is broken off approx.46 mm away from the cannula hub.The structure of the break shows that the pencan cannula was bent before breaking.The broken off part including the cannula tip was handed over by the customer.In addition, the outside diameter of the pencan cannula was measured according to the drawing.Nominal-value: 0.42 +0.01/-0 mm.Actual-value of the used sample: 0.42 mm.The measured value (outside diameter) of the pencan cannula is within our specification.As the measured value is within our specification and the sample was already used, we assume problem during the application process.We have informed our manufacturing department accordingly.Further investigation was conducted using retention samples.Functional inspection: stiffness test.Test conducted using retention sample: mat no.4502052n-01x.Batch no.17n06h8b22.Company specifications: max 0.65mm.Results: 0.356mm (pass).Device history record: no abnormalities found from reviewing the batch records for batch no.17n06h8b22.Therefore this complaint is 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.

Event Description

As reported by the user facility ((b)(4)): needle has broken in half.Spinal needle has broken in half whilst in a patient.

• Brand Name: PENCAN
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon boulevard; allentown, PA 18109 ; 4842408332
• MDR Report Key: 9315222
• MDR Text Key: 166153646
• Report Number: 9610825-2019-00524
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2019

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 Expiration Date: 12/06/2022
• Device Model Number: N/A
• Device Catalogue Number: 4502052N-01
• Device Lot Number: 17N06H8B22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2017
• 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