MAUDE Adverse Event Report: BECTON DICKINSON 20127E-EXT SET 1.2MF 1SS DEHP FREE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	20127E
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Hold for rw 2.5 material#: 20127e.Lot#: 23099460.It was reported by the customer reported that tpn and smof lipids has been infusing all night the line was checked for kinks, bubbles, and if it was clamped because the pump kept reading high pressure and would only stop alarming if the pressure setting on the pump was turned up.No patient harm.Verbatim: rcc received a complaint via phone.Pir attached.Tpn and smof lipids has been infusing all night until about 0530 on 01/04/2023.The line was checked for kinks, bubbles, and if it was clamped because the pump kept reading high pressure and would only stop alarming if the pressure setting on the pump was turned up.
Additional Manufacturer Narrative
(b)(4): 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
No additional info.
Additional Manufacturer Narrative
The customer reported that the set occluded.One sample model 20127e, lot 23099460 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a bd primary set and primed with 85% glycerin / 15% water.An infusion run was started at a rate of one ml/hr for 24 hrs.There was no observation of fluid blockage.The customer complaint was unable to be replicated.See the attached ¿filtering out the facts: recommendations to optimize performance of in-line filters for parenteral nutrition and intravenous fat emulsion infusions (ivfe)¿ for additional information regarding the use of ivfe with in-line filter administration sets.Although the issue was unable to be replicated and the root cause is unknown bd is looking at opportunities to improve the filter function to alleviate this failure in the future.

• Brand Name: 20127E-EXT SET 1.2MF 1SS DEHP FREE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18607875
• Report Number: 9616066-2024-00124
• Device Sequence Number: 21114141
• Product Code: FPA
• UDI-Device Identifier: 07613203019248
• UDI-Public: (01)07613203019248
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: 09/30/2026
• Device Catalogue Number: 20127E
• Device Lot Number: 23099460
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown