MAUDE Adverse Event Report: BECTON DICKINSON 105"ADMIN SET 20DP, W/2 Y SITE, CV CLMPS; INTRAVASCULAR ADMINISTRATION SET

Model Number	B2-70072
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that 105"admin set 20dp, w/2 y site, cv clmps had backflow.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported by the customer that the primary set was backflowing into the secondary set.

• Brand Name: 105"ADMIN SET 20DP, W/2 Y SITE, CV CLMPS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12140145
• Report Number: 2243072-2021-01834
• Device Sequence Number: 14403093
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: Other
• Device Expiration Date: 08/04/2023
• Device Model Number: B2-70072
• Device Catalogue Number: B2-70072
• Device Lot Number: 20085276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1