MAUDE Adverse Event Report: BECTON DICKINSON HSCT KOR IV SET TPE GFR SS 5UM P 3W R AP; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 388063

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: 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.Date of event: unknown.The date received by manufacturer has been used for this field.The reported lot # [20200725] was not found for the reported catalog # [388063].Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the hsct kor iv set tpe gfr ss 5um p 3w r ap leaked from the drip chamber while being tested.The following information was provided by the initial reporter: "users testing the product found 1 x drip chamber leak.".

Manufacturer Narrative

Correction: after further review, this complaint will be cancelled, as this product is not a marketed device in the us.

Event Description

It was reported that the hsct kor iv set tpe gfr ss 5um p 3w r ap leaked from the drip chamber while being tested.The following information was provided by the initial reporter: "users testing the product found 1 x drip chamber leak.".

• Brand Name: HSCT KOR IV SET TPE GFR SS 5UM P 3W R AP
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11335381
• MDR Text Key: 245748005
• Report Number: 2243072-2021-00328
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

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
• Device Operator: Other
• Device Catalogue Number: 388063
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1