MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 1000ML; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number	50-7510
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Itching Sensation (1943)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that they had an allergic reaction to the dressing pad from the pleurx kit.Verbatim: rcc received a complaint via email.Email(s) attached patient stated that she had an allergic reaction to the dressing pad from the pleurx kit.(note: complaint was reported by the pt on aug 27; however, due to an oversight the complaint was not processed timely).Product code -db507510 - could you please provide a further description of the issue? having to use medical tape, customer realized that it was just a skin allergy.- what was the impact to the patient? discomfort and itching - had to be prescribed antibiotics.- could you please describe and include any medical intervention required including diagnostics, procedures, and treatment delay? i was prescribed antibiotics.- how was the issue resolved? yes it has been resolved.I use medical tape - where is the catheter located? abdomen or chest - on the abdomen more on the side.- how long has the catheter been in place? i think (b)(6) 2024 - can you please provide the lot number associated with reported issue? no - can you please provide an exact date of event in format dd-mmm-yyyy? can't remember - i think a couple of days after.- is there a photo or sample available showing the reported issue? if yes, please provide mailing address and email address.No available.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.Device problem code: a010102 patient problem code: f23.A probable root cause for this reported failure mode could not be determined since it was not provided enough information to fully investigate this incident as a lot number, photos or physical samples.Examination of the product involved may provide clarification as to the cause for the reported failure.As lot number was not reported it was not possible to do a review of the device history record which allows us to identify, in case it had happened, any rejected inspections or quality issues during the production of the lot number reported.Therefore, it was not possible to identify any finding.

• Brand Name: PLEURX DRAINAGE KIT 1000ML
• 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: brett curtice ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 20286468
• Report Number: 9680904-2024-00019
• Device Sequence Number: 15294476
• Product Code: PNG
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K160437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2024

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: Other
• Device Catalogue Number: 50-7510
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown