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

Catalog Number 102-S10C

Device Problem Burst Container or Vessel (1074)

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

Event Type  malfunction  

Event Description

As reported by the user facility: "around 3 weeks ago nurse attempted to draw up diprium 20cc bottle with a 10cc syringe.When she inserted the syringe (she had withdrawn the plunger about 4-5cc's) it appeared the vacuum was so high that it blew out the bottom of the glass bottle.It shattered in her hand.She had never had this happen before." no sample available.Mfr - 9610825-2014-00205.

• 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 (Section G): B. BRAUN MEDICAL, INC.; 901 marcon blvd.; allentown PA 18109 934
• Manufacturer Contact: 901 marcon blvd.; allentown, PA 18109-9341
• MDR Report Key: 3854245
• MDR Text Key: 4657366
• Report Number: 2523676-2014-00205
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2014,05/09/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102-S10C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/28/2014
• Distributor Facility Aware Date: 05/09/2014
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1