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

Model Number N/A

Device Problem Break (1069)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).No sample has been returned for investigation.Without the actual sample (or device), a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.A follow-up report will be provided after the review of the dhr was done.

Event Description

As reported by the user facility ((b)(4)): needle-damaged-broken.

Manufacturer Narrative

(b)(4).No sample has been returned for investigation.Without the actual sample (or device), a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.Review of manufacturing records: no abnormality was found.

• 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: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 6113324
• MDR Text Key: 60360092
• Report Number: 9610825-2016-00801
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2017,10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2021
• Device Model Number: N/A
• Device Catalogue Number: 4502043-13
• Device Lot Number: 16E16H8B21
• 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: 02/03/2017
• Distributor Facility Aware Date: 10/26/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2017
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2016
• 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
• Patient Outcome(s): Other