MAUDE Adverse Event Report: B. BRAUN MEDICAL INC CARESITE®; SET, ADMINISTRATION, INTRA

Catalog Number	470100-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: event 1: we are having issues with caresite smallbore extension set (470100-01) detaching from iv cannulas.On speaking to the customer she gave me further information.This has happened 5 times the first time the baby lost a significant amount of blood and the babies hemoglobin level dropped by half.The hospital has not experienced any further injuries, as far as the nurse knows.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The actual defective device is valuable tool in investigating the cause of this incident.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.The initial mdr was submitted on time but failed.Failure occurred due to submission uploaded as a.Pdf instead of a.Xml file.Messageid: <42538441.10.1700599993574@us01-c1315.Bbmus.Bbraun.Com> coreid: ci1700599993336.1921771@fdsahl86ceb429_te2 datetime receipt generated: (b)(6) 2023, 15:53:56."cdrh has received your submission".

• Brand Name: CARESITE®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 901 marcon ave; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon ave; allentown, PA 18109 ; 4847197289
• MDR Report Key: 18336958
• Report Number: 2523676-2023-00755
• Device Sequence Number: 8415841
• Product Code: FPA
• UDI-Device Identifier: 04046964093715
• UDI-Public: (01)04046964093715
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 470100-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown