MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG SPINOCAN; 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	05/24/2018
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 is currently on shipping from brazil to bbm in germany for investigation.A follow-up report will be provided after the inspection results are available.Device history record (dhr): /reviewed the complaint batch and no abnormality found during in-process and at final control inspection.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in brazil): broken/ needle.
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 spinocan 27gx3 1/2" (0.42x88 mm) in open packaging.The received sample was taken to a visual inspection.The used spinocan cannula is broken off approx.43 mm away from the cannula hub and the part with the cannula tip is bent.The structure of the break of the raw cannula shows that the cannula was repeatedly bent before the break.In addition, this shape resembled the shape of a broken cannula deliberately bent.Anomalies in which cannula folds and bends do not occur in the manufacturing process and transportation.In addition, the outside diameter of the spinocan cannula was measured according to drawing.Nominal-value: 0.42 +0.01/-0 mm.Actual-value: used sample = 0.42 mm.The measured value (outside diameters) of the spinocan cannula is in accordance with our specification.With regard to the used sample we assume of a problem during application and consider the complaint not confirmed.

• Brand Name: SPINOCAN
• Common Device Name: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 8106123
• Report Number: 9610825-2018-00253
• Device Sequence Number: 16709575
• Product Code: BSP
• UDI-Device Identifier: 04046964833205
• UDI-Public: (01)04046964833205(17)201130(10)15N29G8653
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K820047
• 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): 02/07/2019
• Report Date (Section F): 02/07/2019

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 4503902
• Device Lot Number: 15N29G8653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/27/2018
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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: 02/07/2019