MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO ONE-LINK NEUTRAL LUER ACTIVATED DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 7N8399

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The devices were not returned and the lot numbers were unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified number of connection difficulties occurred while using one-link neutral luer activated devices directly connected to the patients¿ catheter hubs with no extension sets.It was further stated that the customer "knew ahead of time that iv (intravenous) complications might happen without using the extension set due to the extra manipulation (twisting and turning) when connecting and disconnecting iv components".There was no patient injuries or medical interventions associated with these events.No additional information is available.

Manufacturer Narrative

This was previously reported as the customer ¿had connection difficulties when using the baxter one-link neutral luer activated device directly connected to patients¿ catheter hubs with no extension sets¿.Upon further review of the information provided, there was no indication that the one-link neutral luer activated device failed to work according to specifications.Therefore, the baxter device is no longer considered a suspect product problem/malfunction related to this event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ONE-LINK NEUTRAL LUER ACTIVATED DEVICE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8200927
• MDR Text Key: 131545903
• Report Number: 1416980-2018-08036
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/29/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 7N8399
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 12/28/2018
• Supplement Dates FDA Received: 12/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1