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

Catalog Number	INCORRECT ENTRY
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a020701.Patient problem code: f27.
Event or Problem Description
During the import inspection of bd-047, some crushed boxes were identified.Item c08293 - 50-9050a came missing 3 boxes (30 units), in addition to 2 units of the same item with damages.- was the peritx catheter kit/tray damaged during transportation? we are unable to say when the products were damaged, whether it occurred during transportation or if they left the factory that way.- if so, what is the total number of occurrences/quantities associated with damaged trays? damaged trays: 2 units.- missing trays: 30 units (3 boxes).- please indicate the number of crushed boxes.2 boxes.
Event or Problem Description
During the import inspection of bd-047, some crushed boxes were identified.Item c08293 - 50-9050a came missing 3 boxes (30 units), in addition to 2 units of the same item with damages - was the peritx catheter kit/tray damaged during transportation? we are unable to say when the products were damaged, whether it occurred during transportation or if they left the factory that way.- if so, what is the total number of occurrences/quantities associated with damaged trays? damaged trays: 2 units.- missing trays: 30 units (3 boxes).- please indicate the number of crushed boxes.2 boxes.
Additional Manufacturer Narrative
(b)(4).Follow-up emdr for device evaluation: four photos sample were provided to our quality team for evaluation.During visual inspection, it was observed that the boxes and trays have sustained significant damage; therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001562439 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.The sterilization record for was reviewed, no issues were observed and there was no damage reported.Based on the available information we are not able to identify a root cause at this time.A notification will be sent to the distribution center to raise awareness.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.
Additional Manufacturer Narrative
H10: the parent record was reopened following an email request for correction.According to the email, 'the third line of this complaint is unnecessary, as the customer mentions two affected units.' based on additional information received quantity affected change from four to two.Supplemental mdr will be submitted to reflect this change.
Event or Problem Description
During the import inspection of bd-047, some crushed boxes were identified.Item c08293 - 50-9050a came missing 3 boxes ((b)(4) units), in addition to (b)(4) units of the same item with damages.Additional information received on 19 aug 2024: please indicate the number of crushed boxes.2 boxes.Additional information received on 21 aug 2024: was the peritx catheter kit/tray damaged during transportation? we are unable to say when the products were damaged, whether it occurred during transportation or if they left the factory that way.If so, what is the total number of occurrences/quantities associated with damaged trays? damaged trays: (b)(4) units.Missing trays: (b)(4) units (3 boxes).

• Brand Name: PERITX PERITONEAL CATHETER MINI KIT
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: brett curtice ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 20108983
• Report Number: 1625685-2024-00102
• Device Sequence Number: 12904588
• Product Code: PNG
• UDI-Device Identifier: 10885403500831
• UDI-Public: (01)10885403500831(11)240404(17)270331(10)0001562439
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K160437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: INCORRECT ENTRY
• Device Lot Number: 0001562439
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 10/14/2024; 01/16/2025
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 10/14/2024; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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