MAUDE Adverse Event Report: EXTENSION SET; SET, ADMINISTRATION, INTRA

Model Number	470172
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: end user reports: "iv tubing was stuck connected to extension set.Rn pulled on tubing to remove.Plastic piece broke off of iv tubing in extension set causing a vacuum where the patient's blood began pouring out of the extension set." note: extension set was attached to non-b.Braun pump infusion set.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was provided for evaluation.The set was decontaminated and visually evaluated.A competitors set was also returned and found that the competitors pc broke in the b.Braun extension set caresite valve.Based on the evaluation results, the reported defect is not confirmed to be a manufacturing defect.Previous engineering testing cited a probable root cause could be alcohol exposure of certain male adapters, which can lead to difficulty removing or breakage of male luer tapers when connected to female luers.Per the ifu, "swab top lad vigorously for 15 seconds with 70% isopropyl alcohol and allow to air dry prior to use." please note the air drying of the alcohol prior to use.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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.

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• MDR Report Key: 12172290
• Report Number: 2523676-2021-00213
• Device Sequence Number: 1631846
• Product Code: FPA
• UDI-Device Identifier: 04046964580215
• UDI-Public: 04046964580215
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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 Expiration Date: 02/29/2024
• Device Model Number: 470172
• Device Catalogue Number: 470172
• Device Lot Number: 0061769344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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