MAUDE Adverse Event Report: EXCELSIOR MEDICAL ZR SWABFLUSH 10ML; SALINE FLUSH

Model Number P/N: SCXT3

Device Problems Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 04/15/2014

Event Type  malfunction  

Event Description

A nuclear medicine technician peeled back the closure on a swabflush (swabcap) 10ml ns flush syringe and saw dark spots around the orange ring.She didn't use it but instead brought it to the pharmacy dept.The pharmacist notified the material management dept that orders and stocks the product, and also the hospital's infection control practitioner who contacted the mfr's sales rep.Reason for use: needed to flush line but didn't use the dose.

• Brand Name: ZR SWABFLUSH 10ML
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): EXCELSIOR MEDICAL; neptune NJ 07753
• MDR Report Key: 3763597
• MDR Text Key: 4488065
• Report Number: MW5035728
• Device Sequence Number: 1
• Product Code: NGT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Model Number: P/N: SCXT3
• Device Lot Number: 3116862
• Other Device ID Number: 0 0363807 10301 6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1