MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG DISCOFIX®; STOPCOCK

Model Number N/A

Device Problem Blocked Connection (2888)

Patient Problem No Information (3190)

Event Date 07/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample has been returned for investigation.The batch record could not be reviewed since the lot number is not known.Without the actual sample or lot number, a thorough investigation can not be performed.All available information has been forwarded to the actual manufacturer.If the sample or lot number and/or additional pertinent information becomes available, a follow up report will be filed.

Event Description

As reported by the user facility ((b)(4)): stopcock-function-blockage.

Manufacturer Narrative

(b)(4).List of batch numbers received by customer between january 2015 and today (08/29/2016) 16e1692040; 16e1592051; 16e0592040; 16d1492040; 16d1092041; 16c1092040; 16c0392040; 16c0292040; 16b1592040; 16a3192042; 16a1292041; 16a1092040; 15l2892040; 15l1592040; 15k1992045; 15k1492041; 15i2892040; 15i1092047; 15i0192041; 15h2792041; 15h1992040; 15g1192045; 15f2792040; 15e1092041; 15d1892040; 15c2192040; 15c1392046; 15c0192041; 15b1892046; 15b0192043; 15a0592045; 14m1692040; 14m0492040.All batch-numbers as listed in the customer complaint have been checked for documented irregularities or abnormalities.Results: no irregularities or abnormalities were documented which can be associated with the fault.

• Brand Name: DISCOFIX®
• Type of Device: STOPCOCK
• 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: 5911135
• MDR Text Key: 53392355
• Report Number: 9610825-2016-00585
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K760383
• 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: 09/20/2016,08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4095111
• Device Lot Number: UNKNOWN
• 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: 09/20/2016
• Distributor Facility Aware Date: 08/04/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2016
• Date Manufacturer Received: 08/04/2016
• 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