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

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is currently on shipping from (b)(4) to bbm in (b)(4) 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 Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): broken/ needle.

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
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 8106123
• MDR Text Key: 128920365
• Report Number: 9610825-2018-00253
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 04046964833205
• UDI-Public: (01)04046964833205(17)201130(10)15N29G8653
• Combination Product (y/n): N
• PMA/PMN Number: K820047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 02/07/2019
• Distributor Facility Aware Date: 11/27/2018
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2019
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/27/2018
• Supplement Dates Manufacturer Received: 11/01/2018
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1