MAUDE Adverse Event Report: BECTON DICKINSON EXT EXTENSION SET WITH MICROCLAVE NFC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	390222
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material# 390222 batch# rehv2546 it was reported by customer that the extension set was leaking blood and had to be disconnected and a new set applied.Verbatim: evn24543041 -- extension set was leaking blood situation: issue: iv was placed and the extension set was leaking blood and had to be disconnected and a new set applied.Pt was anxious about iv and it complicated the experience.Ref 390222, lot #rehv2546.
Additional Manufacturer Narrative
Investigation results: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
No additional information.

• Brand Name: EXT EXTENSION SET WITH MICROCLAVE NFC
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city UT 84116
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19521371
• Report Number: 1710034-2024-00576
• Device Sequence Number: 6425591
• Product Code: FPA
• UDI-Device Identifier: 00382903902224
• UDI-Public: (01)00382903902224
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K200439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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: 07/31/2026
• Device Catalogue Number: 390222
• Device Lot Number: REHV2546
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown