MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S); INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZ9266

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

It was reported while using bd maxzero multi-fuse extension set with needleless connector(s) the connector was unable to connect properly.This is report 4 of 6.There was no report of patient impact.The following information was provided by the initial reporter: 1.After 0730 sodium acetate repletion, i went to hook xx up to his ns tko line.When i attached the trifercate to his lumen, the trifercate snapped and broke at the connector.Serial (b)(6) lot #22129210 2.This rn disconnected 3-lumen multicolor trifurcate (red, white, blue) from patient port to draw labs and connecting hub piece of trifurcate broke off.Unknown how long piece was cracked/broken.Possible risk of clabsi.(unable to report) 3.Pt had a trifurcate attached to his picc.The cap of the trifurcate attached to the patient was found to be cracked and broken at the luerlock connection piece.Broken line was saved and given to 3f cns ((unable to report) 4.Unable to reconnect pt's trifuse d/t malfunctioning trifuse connector.5.End of trifurcate cracked serial (b)(6).Lot #20319245 6.Bedside rn bia alves noticed patient's lines were leaking at the cap site.I was at the bedside and we thought it was the line.Changed the tubing on the red lumen and then noticed when flushed that the cap was still leaking.Unsure where it is leaking from but blood was stuck in the cap and leaking.Cap change performed on both lumens.

Manufacturer Narrative

D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 27-jul-2023.H6: investigation summary : the customer reported the trifurcate was broken, and returned one used sample for this investigation.The sample had a cracked luer collar, rendering the luer connection useless.The complaint is verified.There were 5 samples in total, 2 of the 5 had no luer collar returned at all, 2 more had the luer collar cracked and broken but returned, and the remaining sample had a cracked luer collar but it was still attached to the trifurcate.All samples show the same failure, and the crack in the luer was at the top.The root cause is traced to alcohol used on the luer collars.The alcohol disinfectant process can weaken the plastic.

Event Description

It was reported while using bd maxzero multi-fuse extension set with needleless connector(s) the connector was unable to connect properly.This is report 4 of 6.There was no report of patient impact.The following information was provided by the initial reporter: 1.After 0730 sodium acetate repletion, i went to hook xx up to his ns tko line.When i attached the trifercate to his lumen, the trifercate snapped and broke at the connector.Serial (b)(6) lot #22129210.2.This rn disconnected 3-lumen multicolor trifurcate (red, white, blue) from patient port to draw labs and connecting hub piece of trifurcate broke off.Unknown how long piece was cracked/broken.Possible risk of clabsi.(unable to report) 3.Pt had a trifurcate attached to his picc.The cap of the trifurcate attached to the patient was found to be cracked and broken at the luerlock connection piece.Broken line was saved and given to 3f cns ((unable to report) 4.Unable to reconnect pt's trifuse d/t malfunctioning trifuse connector.5.End of trifurcate cracked serial (b)(6).Lot #20319245 6.Bedside rn bia alves noticed patient's lines were leaking at the cap site.I was at the bedside and we thought it was the line.Changed the tubing on the red lumen and then noticed when flushed that the cap was still leaking.Unsure where it is leaking from but blood was stuck in the cap and leaking.Cap change performed on both lumens.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S)
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17321391
• MDR Text Key: 319846885
• Report Number: 9616066-2023-01440
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403240789
• UDI-Public: (01)20885403240789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MZ9266
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1