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

Model Number	V1390
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	Pain (1994)
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 that the tubing is stiffer, though it isn't as big of a deal as the roller clamp.The roller clamp is made of harder/sharper plastic and the roller is more difficult to roll up and down, which makes it painful and the drip rate is not as accurate.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.Two (2) photographs of two (2) sets of roller clamps were provided for evaluation.A visual evaluation was performed on the photographs and it is difficult to determine the reported defect without the physical sample.It was noted that in the photographs the two (2) sets have different roller clamps that were also included in the resilia project.Investigation by the dominican republic team identified a project which was implemented to produce tubing size 3x4.1mm, structure coil form and cut lengths of this tubing in addition to changing the drip chamber and roller clamp of the set.The discoloration and stiffness reported in this and similar complaints have been determined to be expected changes that are within specification.Testing of the product determined that there have been no significant changes to the form, fit, or function of the product.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: IV ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• MDR Report Key: 12323883
• Report Number: 2523676-2021-00278
• Device Sequence Number: 19908793
• Product Code: FPA
• UDI-Device Identifier: 04046964188176
• UDI-Public: 04046964188176
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K173361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: 03/31/2026
• Device Model Number: V1390
• Device Catalogue Number: V1390
• Device Lot Number: 0061777755
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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