MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG SANGOFIX®; BLOOD ADMINISTRATION SETS VENTED AND NON-VENTED

Catalog Number 4034228

Device Problem Air/Gas in Device (4062)

Patient Problem Pulmonary Embolism (1498)

Event Date 03/20/2023

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).The complaint is under investigation.A follow-up will be provided after the investigation 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 france."air in the tubing." according to the customer: "presence of air in the tubing.Possible gas embolism, stable patient since.".

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).We received one used sangofix 180cm, spinlock/primestop without packaging and in connection with a blood bag.The received sample was taken to a visual inspection according to the test method damages.We detected no damages or manufacturing faults.The tube was completely empty.Afterwards, a functional test in connection with a 500 ml ecoflac (nacl 0.9%) was carried out at the sample.After filling the bottom chamber with nacl 0.9 % up to the white ring the solution is running without problems.Adjusting of different drop rates as well as stopping the infusion was possible without any difficulties.Moreover, the sample was tested for air tightness according sap test plan and test method tightness.Leaks were not detected at the received samples.A review of the batch and manufacturing record revealed no abnormalities or nonconformities.Based on the conducted investigations the received sample is within the specifications.Therefore, the complaint is considered as not confirmed.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: SANGOFIX®
• Type of Device: BLOOD ADMINISTRATION SETS VENTED AND NON-VENTED
• 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, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16867702
• MDR Text Key: 314545026
• Report Number: 9610825-2023-00159
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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: 4034228
• Device Lot Number: 22E04K8412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention