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	05/23/2018
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).The device has not yet been returned for investigation.A review of the batch and manufacturing records revealed no abnormalities or nonconformities.A follow-up report will be provided after the inspection results are available.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in france: needle-damaged-broken.
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 27gx3 1/2" (88mm) m.Fk-eu/ap/sa without packaging.The returned sample was subjected to a visual examination.The used pencan cannula is broken off approx.47 mm away from the cannula hub.The structure of the break shows that the cannula was bent before break.The broken off part including the cannula tip was not handed over.In addition, the outside diameter of the pencan cannula was measured according to drawing.Nominal-value: 0.42 mm +0.01/-0 mm actual-value: 0.42 mm the measured value (outside diameter) of the pencan cannula is within the specification.We assume of a problem during the application and consider the complaint to be not confirmed.The complained sample was forwarded to our manufacturing site for evaluation: manufacturing records had no abnormality.We guessed that this abnormality occurred because cannula was bent many times.This abnormality occurred in surgical procedure.Measurement value of stiffness test of retention sample was within our specification.

• 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: 7614841
• Report Number: 9610825-2018-00108
• Device Sequence Number: 19271005
• Product Code: MIA
• UDI-Device Identifier: 04046964180941
• UDI-Public: (01)04046964180941(17)221016(10)17L16H8B21
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 11/27/2018
• Report Date (Section F): 11/27/2018

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: 10/16/2022
• Device Model Number: N/A
• Device Catalogue Number: 4502051-13
• Device Lot Number: 17L16H8B21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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: 11/27/2018