MAUDE Adverse Event Report: CAREFUSION PLEURX PLEURAL CATHETER MINI KIT; APPARATUS, SUCTION, PATIENT CARE

Model Number 50-7050

Device Problems Break (1069); Crack (1135)

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

Event Date 05/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial emdr submission.A follow up emdr will be submitted upon receipt of additional information and/or completion of investigation.

Event Description

Medical specialties - broken the nose of the safety valve is broken.The valve cap now is fixed by tape (leukoplast).Neither patient injury nor medical intervention has been reported.Additional information received 18 aug 2015: the nose of the safety valve is broken and had to be replaced.The safety valve is cracked and had to be replaced.The nose of the safety valve is broken.The valve cap now is fixed by tape (leukoplast): fixing the valve cap with a tape; is it risky / work it correctly for next drainage ? it is still possible to drainage.

Manufacturer Narrative

(b)(4): #2 follow up emdr.A complaint sample or sample picture was not provided for evaluation.Consequently, the investigation could not evaluate nor confirm the reported failure mode.A review of applicable device history records could not be performed since a lot number was not reported in the incident report.The investigation was not able to identify a probable root cause for the reported failure mode since no complaint sample and no lot information was provided for review.Likewise, a review of the current manufacturing process did not identify any step that may have contributed to the report failure mode.However, as the trending report indicates, we have seen other instances of this failure and have reached out to our supplier of the plastic cap to investigate their processes for possible root cause and corrective actions.Supplier corrective action request has been issued to the supplier of the plastic cap.

Manufacturer Narrative

(b)(4): follow up emdr for additional information received.Another follow up will be submitted upon completion of investigation.After submission of initial emdr, it was noted that the 510k for peritoneal use was reported instead of the intended 510k for pleural use.

Event Description

Is the lot # available? no lot# available if no, does the valve have pleurx printed on it? no information available.What was the original implant date to the patient? (b)(6) 2015.Is the patient currently receiving chemotherapy? no information available.What is the customer using to disinfect the valve? 50-7290: alcohol pads.Is the drainage being performed by a healthcare provider or a personal patient caregiver(unlicensed)? no information.How frequently is the patient receiving drainage? most of them daily.Is the patient undergoing radiation to the area where the catheter is placed? no information available.Pleural or peritoneal? you can't always be sure by the cat code used.Pleural.Did they experience any difficulty attaching the cap or lockable drainage line at any point? in what way was it difficult? no information available.Did the nose become bent at any time before it broke off? for example, did it bend on one drainage and then break on another occasion? might be possible.Do they notice anything different about the catheter tubing compared to what they've seen on other patients? no information available.Is there any patient information available? (b)(6).

• Brand Name: PLEURX PLEURAL CATHETER MINI KIT
• Type of Device: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 400 east foster rd; mannford 74044
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5063786
• MDR Text Key: 26072015
• Report Number: 1625685-2015-00195
• Device Sequence Number: 1
• Product Code: DWM
• Combination Product (y/n): N
• PMA/PMN Number: K112851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 50-7050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR