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

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No sample has been returned for investigation.The batch record could not be reviewed since the lot number is not known.Without the actual sample or lot number, a thorough investigation can not be performed.All available information has been forwarded to the actual manufacturer.Note: this report is being filed for the product problem.A second report was filed for the same event, under mfr report number 9610825-2017-00240, to capture the adverse event that required surgical intervention.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): broken cannula.About 3 cm left inside of patient, which required an extra operation to remove.

• Brand Name: PENCAN
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown 18109 ; 4842408332
• MDR Report Key: 7095893
• MDR Text Key: 94119317
• Report Number: 9610825-2017-00241
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K112515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4454820
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2017
• Distributor Facility Aware Date: 12/07/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2017
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1