MAUDE Adverse Event Report: CAREFUSION CORPORATION SMALLBORE EXTENSION SET

Model Number 20043E

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Type  malfunction  

Event Description

Customer reported visible pinhole(s) on the extension tubing approximately 1 to 1.5 inches from the end of the tubing resulting in fluid or blood leaking and spraying when the nurse attempts to flush.Leak was observed around clave/extension connection at beginning of use.There was no pt harm or medical intervention.Customer states that no further pt/event info is available.

Manufacturer Narrative

Manufacturer's report date: 03/26/2014.Internal file no: (b)(4).The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

• Brand Name: SMALLBORE EXTENSION SET
• Manufacturer (Section D): CAREFUSION CORPORATION; san diego CA
• Manufacturer Contact: michelle bitto ; 10020pacific mesa blvd.; san diego, CA 92121 ; 8586173316
• MDR Report Key: 3851354
• MDR Text Key: 4656746
• Report Number: 9616066-2014-00253
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Model Number: 20043E
• Device Catalogue Number: 20043E
• Device Lot Number: 13066691
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2013
• 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: ANGIOCATH CATHETER: 382533, LOT UNK; LIFESHIELD PRIMARY SET: 12662/28, LOT UNK; HOSPIRA CLAVE: 11956, LOT UNK, THERAPY DATE UNK; THERAPY DATE UNK