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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016018 b.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun melsungen ag internal report # (b)(4).We received one used pencan 25gx3 1/2" (88mm)m.Fk-eu/ap/sa without packaging and one sample in original closed packaging.The returned samples were taken to a visual examination.The used pencan cannula is broken off approx.50 mm behind the cannula hub.We detected kinks approx.60 mm and 70 mm behind the cannula hub.At the tip of the cannula no damages were detected.The structure of the break shows that the cannula was bent before break.At the original packed sample we detected no damages.In addition, the outside diameter of the pencan cannulas were measured according to drawing.Nominal-value: 0.53 mm +0.01/-0 mm.Actual-values: used sample = 0.53 mm.Actual-values: unused sample = 0.53 mm.The measured values (outside diameters) of the pencan cannulas are within the specification.With regard to the used sample we assume problem during application.Review of manufacturing records: any abnormality was not found.Stiffness test; batch no.18c20h8b21 - retention sample - standard: max 0.43mm span 10.0mm load 7n result: 0.350mm - pass - this complaint is not confirmed.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in germany): needle tip is broken off.

• Brand Name: PENCAN
• Common Device Name: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 8160545
• Report Number: 9610825-2018-00264
• Device Sequence Number: 11334697
• Product Code: MIA
• UDI-Device Identifier: 04046964180644
• UDI-Public: (01)04046964180644(17)230320(10)18C20H8B21
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2018
• Report Date (Section F): 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2023
• Device Model Number: N/A
• Device Catalogue Number: 4502043-13
• Device Lot Number: 18C20H8B21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/13/2018
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/13/2018