MAUDE Adverse Event Report: BECTON DICKINSON Y EXT W/VLV PORTS & 2 SLD CLP; INTRAVASCULAR ADMINISTRATION SET

Model Number	20019E
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that a y ext w/vlv ports & 2 sld clp had flow issues and was clogged during use.The following was reported by the initial reporter: "unable to draw blood or flush.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-06-03.H6: investigation summary: the customer reported they were unable to draw blood or flush, and returned 3 used samples of model #20019e.The samples were tested first with a cut off syringe to see if the blue piston was occluded or not, and then flushed with water.There were 2 failures in the 3 samples, and the complaint is verified.A device history record review could not be performed on material #20019e because a valid lot number was not provided by the customer.A root cause was unable to be determined.A trend for this occlusion issue has been identified for this product line.A capa (corrective action preventative action) 1998036 has been initiated, and a team has been assembled in order to investigate the issue.
Event or Problem Description
It was reported that a y ext w/vlv ports & 2 sld clp had flow issues and was clogged during use.The following was reported by the initial reporter: "unable to draw blood or flush".

• Brand Name: Y EXT W/VLV PORTS & 2 SLD CLP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11925728
• Report Number: 2243072-2021-01578
• Device Sequence Number: 19063099
• Product Code: FPA
• UDI-Device Identifier: 27613203013813
• UDI-Public: 27613203013813
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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 Model Number: 20019E
• Device Catalogue Number: 20019E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1