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

Catalog Number	50-7510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr 8411590 initial emdr submission.A follow up emdr will be submitted if additional information becomes available.
Event or Problem Description
It was reported: customer received kit with defective issue.No patient harm.Event description states: cracked tubing no suction 1 bottle.Questions: - was it the access tip that was cracked? tubing of the bottle and little plastic beads inside the tubing.So vacuum was not working, seemed as if it was blocked.- was the drainage line cracked? - was the cracked and no suction issue happened on same bottle? or two different bottles involved? one bottle - was the issue identified before use and the product discarded or did, they identify the crack during use? before use - is there a photo or sample available showing the reported issue? no - if sample is available, please advise email and address for return label.Na - are they able to drain successfully with the new bottle? had to open a new kit.- what is the lot number? 0001507170 - where is the catheter located? abdomen or chest one on the right and one on the left - what was the impact to the patient? - were there any sounds or hissing? no - how were bottles stored before use? keep them in the box stored in dining room.
Event or Problem Description
It was reported: customer received kit with defective issue.No patient harm.Event description states: cracked tubing no suction 1 bottle.Questions: - was it the access tip that was cracked? tubing of the bottle and little plastic beads inside the tubing.So vacuum was not working, seemed as if it was blocked.- was the drainage line cracked? - was the cracked and no suction issue happened on same bottle? or two different bottles involved? one bottle.- was the issue identified before use and the product discarded or did, they identify the crack during use? before use.- is there a photo or sample available showing the reported issue? no.- if sample is available, please advise email and address for return label.Na.- are they able to drain successfully with the new bottle? had to open a new kit.- what is the lot number? 0001507170.- where is the catheter located? abdomen or chest one on the right and one on the left - what was the impact to the patient? - were there any sounds or hissing? no.- how were bottles stored before use? keep them in the box stored in dining room.
Additional Manufacturer Narrative
(b)(4).Follow-up emdr for device evaluation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001507170 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.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.

• Brand Name: PLEURX DRAINAGE KIT 1000ML
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• 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: 17390627
• Report Number: 9680904-2023-00026
• Device Sequence Number: 6770526
• Product Code: DWM
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: Lay User/Patient
• Device Expiration Date: 08/05/2025
• Device Catalogue Number: 50-7510
• Device Lot Number: 0001507170
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2023
• 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