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

Catalog Number 409511CN

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.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 / translation of user facility information by bbm sales organization in china: ":unidentified blue substance of three-way stopcock came off with foreign matter, which was a product quality problem." according to the customer: "comminuted fracture of left distal radius and ulna; this product is applicable to infusion therapy and pressure monitoring.Description of event:the patient was admitted due to comminuted fracture of left distal radius and ulna and underwent internal fixation on september 27.After operation, indwelling right dorsal vein indwelling needle connected with analgesic pump was indwelled to relieve pain.At 9:30 on september 28, the infusion was started on that day.Since the indwelling needle only had one port, the disposable pressure extension tube was connected and the three-way connection was made.Connect one end of the tee to a disposable portable infusion pump and the other end to an intravenous infusion fluid.The patient was given normal saline flushing, and complained no local discomfort of indwelling needle.At about 11:30, 5 ml normal saline was flushed and sealed at the end of infusion, and the indwelling needle was connected with analgesic pump for continuous administration for pain relief.At about 12:35, the patient 's family called and found blue foreign body in the connecting tube.So, the nurse immediately went to ward to check the pipeline, and found 3 blue unidentified objects at the exit of tee and in the connecting pipe.The analgesic pump was immediately clamped, and the patient was examined and asked whether there was discomfort.The patient complained of no discomfort.The patient was comforted, and the doctor in charge and anesthesiologist were called.At about 13:10, anesthesiologist came to the scene to check the patient, and replaced the connecting tube and three-way connection.The patient felt a foreign body came into the body.".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).We received two customer pictures of a discofix-3 blau 2ver ms "cn" in connection with an extension line.We detected that inside the tube are blue particles at two places.Further we received 14 discofix-3 blau 2ver ms "cn" in original packaging.All received samples were taken to a visual inspection according to visual inspection for inclusions according to the test method cleanliness.Particles or manufacturing faults were not detected at the 14 received samples.Afterwards we injected nacl 0.9 % with a omnifix syringe through the discofix-3 blau 2ver ms "cn" in several cock positions at all samples.Particles were not detected during the functional inspection.Based on the conducted investigations the 14 tested samples are within the specification.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.

• 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: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15723575
• MDR Text Key: 307598076
• Report Number: 9610825-2022-00457
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K760383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 409511CN
• Device Lot Number: 21G18D9044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2022
• 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