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	04/27/2018
Type of Reportable Event	Serious Injury
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) at this time, the device was not yet returned for evaluation.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 poland: broken needle.
Additional Manufacturer Narrative
Exemption number e2016018 b.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun (b)(4) ag (manufacturer).This report has been identified as b.Braun (b)(4) ag internal report # (b)(4).We investigated our manufacturing records and any abnormality were not found.We received one used pencan 27gx3 1/2" (88mm) w.Int.-eu/ap/sa with open packaging.The returned sample was taken to a visual examination.On the sample the cannula is broken off.The broken off segment was not handed over by customer.The structure of the break of the raw cannula shows that the cannula was bent before the break.In addition, the outside diameter of the pencan cannula was measured according to drawing.Nominal-value: 0.42 mm +0.01/-0 mm.Actual-values: used sample= 0.42 mm.The measured values (outside diameters) of the pencan cannula is in accordance with our specification.With regard to the used sample we assume of problem during the application and consider the complaint not confirmed.Correction: this report was originally filed as a product problem report, however additional information was received indicating that an adverse event occured.
Event or Problem Description
As reported by the user facility (translation of user facility information provided by bbm sales organization in poland): broken needle.Patient had to have surgery to remove the broken tip of the catheter.

• 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: 7614842
• Report Number: 9610825-2018-00109
• Device Sequence Number: 1799880
• Product Code: MIA
• UDI-Device Identifier: 04046964180941
• UDI-Public: (01)04046964180941(17)220807(10)17H07H8B21
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 08/30/2018
• Report Date (Section F): 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2022
• Device Model Number: N/A
• Device Catalogue Number: 4502051-13
• Device Lot Number: 17H07H8B21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2018
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 08/30/2018