MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRVASCULAR

Model Number 20128E

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The customer¿s report of broken tubing was not confirmed.An unpackaged, but seemingly unused extension set was received; no issues were observed during visual inspection.A red mark was noted on the male luer, possibly indicating where the tubing broke.No leaks occurred during functional or pressure testing.The customer¿s report of broken tubing was not confirmed.

Event Description

The customer reported that the tubing broke off inside the central line catheter and the patient had to have their central line replaced.There is no report of lasting patient harm.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, EXTENSION, INTRVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 6152840
• MDR Text Key: 61673901
• Report Number: 9616066-2016-01673
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: 20128E
• Device Catalogue Number: 20128E
• Device Lot Number: 16066011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2016
• 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
• Treatment: CENTRAL LINE CATHETER
• Patient Outcome(s): Other