MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 7N8301

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of a one-link extension set ruptured while in use on a patient during a computerized tomography exam for a pulmonary embolism (pe exam injected at 3.5 cc/sec.).This event occurred in the hospital during the injection of contrast.The reporter stated that ¿after noticing the bolus was suboptimal¿ they checked on the patient and noticed that the patient¿s iv (intravenous) contrast and blood were leaking from a hole in the tubing.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• MDR Report Key: 8449510
• MDR Text Key: 140121580
• Report Number: 1416980-2019-01577
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412475387
• UDI-Public: (01)00085412475387
• Combination Product (y/n): N
• PMA/PMN Number: K132734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

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: Other
• Device Expiration Date: 05/10/2023
• Device Catalogue Number: 7N8301
• Device Lot Number: UR18E10115
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR