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	05/23/2017
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 pencan 27gx3 1/2" (88mm) m.Fk-eu/ap/sa in original packaging.The returned sample was taken to a visual inspection.Damages or manufacturing faults especially at the raw cannula were not detected on the returned sample.In addition, the pencan cannula was taken to a manual function test in combination with the introducer needle.The pencan cannula could be pushed through the introducer needle without any resistance.Withdrawing was also possible without any problems.Function faults were not detected.Furthermore, the outside diameter of the pencan cannula was measured according to the drawing.Nominal: 0.42 +0.01/-0.00 mm (see attached drawing) actual: 0.42 mm the measured outside diameter of the pencan cannula is within the specification.In addition, the pencan cannula was taken to a cannula stiffness test according to the test plan.Nominal: test force = 5.5 n; bending max.= 0.55 mm actual: bending = 0.282 mm the measured value is within the specification.The returned sample is in accordance with the specification.A review of the batch and manufacturing records revealed no abnormalities or nonconformities.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in germany: cannula detached inside patient.

• 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: 6673491
• Report Number: 9610825-2017-00127
• Device Sequence Number: 2059511
• Product Code: MIA
• UDI-Device Identifier: 04046964180941
• UDI-Public: (01)04046964180941(17)211223(10)16N23H8B21
• 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): 06/06/2017
• Report Date (Section F): 06/28/2017

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: 12/23/2021
• Device Model Number: N/A
• Device Catalogue Number: 4502051-13
• Device Lot Number: 16N23H8B21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 06/28/2017
• 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: 06/28/2017