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

Catalog Number	20129E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of occlusion in lipid filter could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 20129e because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• Brand Name: 7 INCH MIC EXT SET W/1.2MF
• Common Device Name: 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
• Report Number: 9616066-2024-00459
• Device Sequence Number: 20475634
• Product Code: FPA
• UDI-Device Identifier: 50885403234901
• UDI-Public: (01)50885403234901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 05/31/2024

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 Catalogue Number: 20129E
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown