MAUDE Adverse Event Report: BECTON DICKINSON 7 INCH MIC EXT SET W/1.2MF; INTRAVENOUS EXTENSION TUBING SET

Catalog Number 20129E

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

Pr 9818519: initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.

Event Description

Materials: 20129e batch#: unknown.It was reported by the customer that lipids were paused for a medication for 15 mins.When the lipids were restarted, the filter was clotted and had to be replaced.Verbatim: rcc received a complaint via email.Email(s) attached.Injuries or adverse event: no.Medline reference #: (b)(4).Item: 20129e.Quantity affected: 1 ea.Serial/lot number: na.Po #:(b)(4).Are any samples available for return? yes.Reported issue per customer: lipids were paused for a medication for 15 mins.When the lipids were restarted, the filter was clotted and had to be replaced.

• Brand Name: 7 INCH MIC EXT SET W/1.2MF
• Type of Device: INTRAVENOUS EXTENSION TUBING SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18969011
• MDR Text Key: 339336141
• Report Number: 9616066-2024-00459
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403234901
• UDI-Public: (01)50885403234901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20129E
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1