MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PENCAN; NEEDLE, CONDUCTION, ANESTH

Catalog Number X0201223

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).We received pictures of one used pencan bulk 0.42x 88 (sp).The pictures were checked visually.Relating to the broken off needle it is not possible to find out the reason for the defect of the complaint based on the pictures.As no sample was provided for investigation a malfunction could not be detected.The complaint is taken to knowledge and filed for statistical purposes.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility ((b)(4)): the needle broken off.A very difficult spinal puncture with significant obesity first attempt with needle g27, to withdraw the needle broken off, estimated to be a part of the 3.5 cm long within, furthermore, with the g25, after a number of attempts to prosper at the deep puncture, spinal channel can only be achieved with the contribution of full-length of the needle.G27 measure, needle, procedure level, the damaged materials removed surgically.

• Brand Name: PENCAN
• Type of Device: NEEDLE, CONDUCTION, ANESTH
• 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, pa ; 2408332
• MDR Report Key: 10398471
• MDR Text Key: 202813064
• Report Number: 9610825-2020-00174
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: X0201223
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2020
• 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
• Patient Outcome(s): Required Intervention