MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 1000ML; APPARATUS, SUCTION, PATIENT CARE

Model Number 50-7510

Device Problem Product Quality Problem (1506)

Patient Problem Tissue Breakdown (2681)

Event Date 02/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon carefusion/bd investigation a follow up emdr will be submitted.(b)(4).

Event Description

Red/purple dots appeared after contact with adhesive provided in the pleurx kit.Skin adhesive ripped some of the skin off after application.Had to turn bandages different directions each day.Even then it was impossible to avoid additional injury.Hospice supplied cavilon no sting barrier film to apply before using your supplied bandaging.Have only had it one day but it seems to be helping.Improving since cavilon became available yesterday.How long was adhesive on prior to being removed? changed once a day, (b)(6).No history of other adhesive problems.

Manufacturer Narrative

(b)(4).One (1) sample from lot #0000866193 was provided for evaluation.Wound dressing was inspected as described per our procedures and no issues were found.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections related to this incident were found.It was confirmed that procedural and functional requirements needed for their release were met.Lot #0000866193 was manufactured on 11/22/2015.Most probable root cause could not be determined since no issues were found during the applicable manufacturing, packaging and inspection processes that can relate personnel, material or method with the reported failure.Even though failure mode could not be confirmed and root cause could not be identified; a notification to supplier has been issued to inform the issue with the affected part.

• Brand Name: PLEURX DRAINAGE KIT 1000ML
• Type of Device: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo ; DR
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628063
• MDR Report Key: 5500861
• MDR Text Key: 40342811
• Report Number: 9680904-2016-00076
• Device Sequence Number: 1
• Product Code: DWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 50-7510
• Device Lot Number: 0000866193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 82