MAUDE Adverse Event Report: CAREFUSION, INC AMNIOCENTESIS TRAY 20G X 3.5IN NEEDLE; SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY)

Model Number 4545A

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) if additional information becomes available as follow up emdr will be submitted.(b)(4).

Event Description

There has been 3 episodes where the vial in the kit shattered within the last 4 weeks.On (b)(6) 2016, a vial shattered and actually punctured the administrator.The reporter definitely believes there is a quality issue.The incident date reflects the first business day of the week the reporter believes the first episode occurred.On (b)(6) 2016; writer spoke with reporter via telephone.She states: received laceration, without need for intervention, ampule(s) appeared to be without defect or anomaly, blue scoring line noted denies any patient harm or impact.Lot number nor sample available.

• Brand Name: AMNIOCENTESIS TRAY 20G X 3.5IN NEEDLE
• Type of Device: SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY)
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628063
• MDR Report Key: 5591768
• MDR Text Key: 43125989
• Report Number: 1625685-2016-00237
• Device Sequence Number: 1
• Product Code: HIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K761230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4545A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other