MAUDE Adverse Event Report: CAREFUSION, INC DRAINAGE DEVICE; NEEDLE, CATHETER

Catalog Number PG1280K

Device Problems Air Leak (1008); Break (1069)

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

Event Date 11/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) - post carefusion investigation; a follow up submission will be done.

Event Description

Inserted into patient with no issues.During drainage nurse saw air coming through the drain when patient in sync with patients breaks.Nurse was concerned and touched the catheter and catheter broke at the connection between the valve and the pig tail catheter.Nurse quickly removed catheter to prevent pneumothorax.New safe-t-centesis was used to continue drainage on the patient and no problems with this product was seen.

Manufacturer Narrative

(b)(4).Our manufacturing quality engineer received one (1) sample from lot #0001098224 for analysis.During visual analysis failure mode could be confirmed as hemostasis valve body was broke as reported.An internal review of the history files for the reported lot number manufactured on 08-may-2017 was also completed confirming procedural and functional requirements needed for the product to be released were met.Despite the failure mode being confirmed, a root cause could not be determined through this investigation.The failure mode will be entered into the complaint management system and will be tracked / trended for any additional similar failure modes.Our bd quality team meets on a monthly basis to review customer complaint trends.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: DRAINAGE DEVICE
• Type of Device: NEEDLE, CATHETER
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061
• MDR Report Key: 7059774
• MDR Text Key: 93335383
• Report Number: 9680904-2017-00223
• Device Sequence Number: 1
• Product Code: GCB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: PG1280K
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other