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	09/10/2018
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 event two of b.Braun melsungen ag internal report #(b)(4).No sample has been returned for investigation.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.1.Retention sample: pencan 27gx3 1/2 (0.4x88mm)-eu mat no.4502027-01xx batch no.18c01h8b23 functional test: stiffness test spec: max 0.65mm retention sample: 0.346mm span: 7.5mm weight: 5.5n result: pass 2.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 norway: event 2 pencan broken inside patient.
Additional Manufacturer Narrative
Exemption number e2016018 (b)(4).This report has been identified as b.Braun melsungen ag internal report # (b)(4).We received one used cannula tip of a pencan 27gx3 1/2" (88mm)-eu without packaging.Furthermore we received one picture, that shows 4 pencan 27gx3 1/2" (88mm)-eu in original closed packaging.The returned sample was taken to a visual examination.The used cannula tip is broken off and the cannula tip is bend.The structure of the break shows that the cannula was bent before breaking.The mandrin was not handed over.In addition, the outside diameter of the cannula tip was measured according to the drawing.Nominal: 0.42 +0.01/-0 mm, actual: used sample = 0.42 mm.The measured value (outside diameters) of the cannula tip is in accordance with our specification.The complained sample was forwarded to our manufacturing site for evaluation: a review of the batch and manufacturing records revealed no abnormalities or nonconformities.1.Visual inspection the cannula was greatly bent at around 30mm from the tip.In addition, the tip was flatness and thin.The tip of cannula which we destroyed intentionally and this abnormality were similar.Justification: we assume wrong handling during application and consider the complaint as not confirmed.

• 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: 7957094
• Report Number: 9610825-2018-00218
• Device Sequence Number: 13831419
• Product Code: MIA
• UDI-Device Identifier: 04046964180941
• UDI-Public: (01)04046964180941(17)230301(10)18C01H8B23
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 01/03/2019
• Report Date (Section F): 01/03/2019

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: 03/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 4502027-01
• Device Lot Number: 18C01H8B23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/09/2018
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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: 01/03/2019