MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG MK SYRINGE 3-P, LL 10CC; SYRINGES

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).The investigation into the reported event is on going at this time.A follow up report will be provided when the investigation results become available.

• Brand Name: MK SYRINGE 3-P, LL 10CC
• Type of Device: SYRINGES
• 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 34212 ; GM 34212 ; 661712769
• MDR Report Key: 3854213
• MDR Text Key: 4681538
• Report Number: 9610825-2014-00205
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K071459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1