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

Catalog Number 4502019

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/02/2014

Event Type  Injury  

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): spinal needle broke off in patient.Needle must be removed with surgical intervention.

Manufacturer Narrative

(b)(4).We received one used pecan 0,53/88 (g25 x 3 1/2") without packaging.The received sample was taken to a visual examination.The pecan cannula was broken off approximately 50 mm away from the cannula hub.The structure of the break point of the raw cannula showed that the cannula was bent before the break.From our point of view the cannula was bent repeatedly in the area of the fracture and this caused the crack of the cannula.The broken-off part with the cannula tip was also assigned by the customer.We have informed our manufacturer accordingly.A follow up report will be provided after their statement is available.(b)(4).

• Brand Name: PENCAN
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen 3421 2; GM 34212
• Manufacturer Contact: ludwig schuetz, safety officer ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4390760
• MDR Text Key: 20777390
• Report Number: 9610825-2014-00465
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/23/2014,12/05/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4502019
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2014
• Distributor Facility Aware Date: 12/05/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2014
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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