MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 500ML 10/CS; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number	50-7500B
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Rash (2033)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Please see this extensive rash.Please see attached email regarding further issues with the tegaderm in the pleurx dressing pack.I have attached the original product complaint form and please see email chain below regarding this same issue.I have no other information regarding this matter and have also not heard of this happening elsewhere.Customer feels that something has changed in the tegaderm that covers the dressing for patients with a plerux.She has experienced patients having soreness / redness and a slight rash after it has been used.26 oct 2023 - response: as far as i can remember, i have sent 2 pictures, but both belong to the same patient and the rash is getting worse as you can see.The lot numbers are not available to me as the dressings are done by the district nurses.The medical intervention needed include steroid treatment, antibiotics and ongoing review.The issue has not fully resolved as the gentleman still ongoing care, but hopefully it might improve as the ipc has now been removed.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a010102.Patient problem code: f23.
Additional Manufacturer Narrative
Pr 9066968 follow-up emdr for device evaluation: one photo sample was received by our quality team for investigation.Upon visual inspection of the photo, it was observed that the catheter is inserted to the patient and the area surrounding the catheter is irritated; therefore, the reported failure mode was confirmed.A device history record could not be evaluated as the lot number is unknown.Based on the available information we are not able to identify a root cause at this time.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
Please see this extensive rash.Please see attached email regarding further issues with the tegaderm in the pleurx dressing pack.I have attached the original product complaint form and please see email chain below regarding this same issue.I have no other information regarding this matter and have also not heard of this happening elsewhere.Customer feels that something has changed in the tegaderm that covers the dressing for patients with a plerux.She has experienced patients having soreness / rendess and a slight rash after it has been used.26 oct 2023 - response.As far as i can remember, i have sent 2 pictures, but both belong to the same patient and the rash is getting worse as you can see.The lot numbers are not available to me as the dressings are done by the district nurses.The medical intervention needed include steroid treatment, antibiotics and ongoing review.The issue has not fully resolved as the gentleman still ongoing care, but hopefully it might improve as the ipc has now been removed.

• Brand Name: PLEURX DRAINAGE KIT 500ML 10/CS
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• 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 ; 8015652341
• MDR Report Key: 18030057
• Report Number: 9680904-2023-00039
• Device Sequence Number: 17873660
• Product Code: PNG
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 50-7500B
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown