MAUDE Adverse Event Report: BECTON DICKINSON AS LVP SS BAG 20D LOW SORB; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	10015862
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
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#: 10015862, batch#: 24066693.It was reported by customer that in the last week, they experienced three instances of faulty iv sets where cytotoxic chemo medication leaked from the bag access port on the side of the bag spike.One instance was caught when the technician had just finished compounding the medication and was still in the iv hood.The other two instances were noticed when the iv set was leaking from the bag access port as they were about to hang the medication for the patient.To fix this, they had to switch the tubing on these three chemo preparations by bringing them back into the iv room.The failed iv sets were ref 10015862 (which failed twice this week) and 2465-0007 (which failed once this week).They reached out to another sanford site, which mentioned having had this issue in the past and had started using an onguard spike adaptor.They began using this adapter today as well but still experienced leakage from the bag access port of the bd set (10015862), even though that port was never utilized during compounding.Rcc received a complaint via email.The failed iv sets are ref 10015862 (occurred twice this week) and 2465-0007 (failed one time this week).We had reached out to another sanford site and they stated this had been an issue for them in the past so they started using a onguard spike adaptor.We transitioned to bd alaris pumps in our infusion center within the last month.In the last week, we have had 3 instances of faulty iv sets where cytotoxic chemo medication is leaking from the bag access port on the side of the bag spike.One of these instances was caught when the technician just finished compounding the medication and was still in the iv hood and two other instances were caught when they noticed the iv set was leaking from that bag access port when they were going to hang the medication for the patient.To fix this, we have had to switch the tubing out on these three chemo preparations by bringing it back into our iv room.The failed iv sets are ref 10015862 (occurred twice this week) and 2465-0007 (failed one time this week).We had reached out to another site and they stated this had been an issue for them in the past so they started using a onguard spike adaptor.We started using this adapter today as well but still ended up having leakage from the bag access port of the bd set (10015862), even though that port was never utilized during compounding.What are the recommended next steps as we need to determine if the lots, we have should be quarantined a new order placed or if there is another practice we should have to avoid this issue? having one leaking iv set and potential chemo exposure is one too many and we have historically had no issues with our previous iv set product that we used for many years.
Event or Problem Description
Material # 10015862.Batch # 24066693.It was reported by customer that in the last week, they experienced three instances of faulty iv sets where cytotoxic chemo medication leaked from the bag access port on the side of the bag spike.One instance was caught when the technician had just finished compounding the medication and was still in the iv hood.The other two instances were noticed when the iv set was leaking from the bag access port as they were about to hang the medication for the patient.To fix this, they had to switch the tubing on these three chemo preparations by bringing them back into the iv room.The failed iv sets were ref 10015862 (which failed twice this week) and 2465-0007 (which failed once this week).They reached out to another sanford site, which mentioned having had this issue in the past and had started using an onguard spike adaptor.They began using this adapter today as well but still experienced leakage from the bag access port of the bd set (10015862), even though that port was never utilized during compounding.Rcc received a complaint via email.The failed iv sets are ref 10015862 (occurred twice this week) and 2465-0007 (failed one time this week).We had reached out to another sanford site and they stated this had been an issue for them in the past so they started using a onguard spike adaptor.We transitioned to bd alaris pumps in our infusion center within the last month.In the last week, we have had 3 instances of faulty iv sets where cytotoxic chemo medication is leaking from the bag access port on the side of the bag spike.One of these instances was caught when the technician just finished compounding the medication and was still in the iv hood and two other instances were caught when they noticed the iv set was leaking from that bag access port when they were going to hang the medication for the patient.To fix this, we have had to switch the tubing out on these three chemo preparations by bringing it back into our iv room.The failed iv sets are ref 10015862 (occurred twice this week) and 2465-0007 (failed one time this week).We had reached out to another site and they stated this had been an issue for them in the past so they started using a onguard spike adaptor.We started using this adapter today as well but still ended up having leakage from the bag access port of the bd set (10015862), even though that port was never utilized during compounding.What are the recommended next steps as we need to determine if the lots, we have should be quarantined a new order placed or if there is another practice we should have to avoid this issue? having one leaking iv set and potential chemo exposure is one too many and we have historically had no issues with our previous iv set product that we used for many years.
Additional Manufacturer Narrative
It was reported by customer that in the last week, they experienced three instances of faulty iv sets where cytotoxic chemo medication leaked from the bag access port on the side of the bag spike.No product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model 10015862 lot number 24066693 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: AS LVP SS BAG 20D LOW SORB
• 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: 20834164
• Report Number: 9616066-2024-01812
• Device Sequence Number: 8627968
• Product Code: FPA
• UDI-Device Identifier: 10885403221866
• UDI-Public: (01)10885403221866(11)240624(17)270624(10)24066693
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 01/22/2025

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: 10015862
• Device Lot Number: 24066693
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown