MAUDE Adverse Event Report: BECTON DICKINSON BD ALARIS¿ LVP 20D LOW SORB SS 1.2M; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10010453
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown h.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the bd alaris¿ lvp 20d low sorb ss 1.2m there is air in the line.The following was received by the initial reporter: the rn is attaching this tubing to the clinimix e tpn fomulation and priming the line and hanging on an alaris pump.But after a few hours, tiny champagne bubbles start to form in the bag and set the pump alarming.
Event or Problem Description
No additional information it was reported that while using the bd alaris¿ lvp 20d low sorb ss 1.2m there is air in the line.The following was received by the initial reporter: the rn is attaching this tubing to the clinimix e tpn fomulation and priming the line and hanging on an alaris pump.But after a few hours, tiny champagne bubbles start to form in the bag and set the pump alarming.
Additional Manufacturer Narrative
No additional information no product or photo was returned by the customer.The customer complaint that there was air in line could not be verified due to the product not being returned for failure investigation.A device history record review for model 10010453 lot number 23075367 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 19jul2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.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.

• Brand Name: BD ALARIS¿ LVP 20D LOW SORB SS 1.2M
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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 NJ 22244
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17865003
• Report Number: 2243072-2023-01777
• Device Sequence Number: 6073451
• Product Code: FPA
• UDI-Device Identifier: 37613203021143
• UDI-Public: (01)37613203021143
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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: 07/18/2026
• Device Catalogue Number: 10010453
• Device Lot Number: 23075367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown