MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PLEURAL CATHETER KIT; APPARATUS, SUCTION, PATIENT CARE

Model Number	50-7000B
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported that customer received opened packaging.Verbatim: pi-is- verbatim: we have found 3 pleurx cath ref 50-7000b ¿ the sterilization wrap has a small tear ( on all 3 ) all in the same corner.The outer wrap is not effected.They couldn¿t use them, due to integrity.They expire today 6/30/22.Patient had delayed treatment and hcp had to open new packs and avoid using these 3.
Event or Problem Description
It was reported that customer received opened packaging.Verbatim: pi-is- verbatim: we have found 3 pleurx cath ref 50-7000b ¿ the sterilization wrap has a small tear ( on all 3 ) all in the same corner.The outer wrap is not effected.They couldn¿t use them, due to integrity.They expire today 6/30/22.Patient had delayed treatment and hcp had to open new packs and avoid using these 3.
Additional Manufacturer Narrative
Pr (b)(4).Follow-up emdr for device evaluation: two photo samples were provided to our quality team for investigation.Upon visual inspection of the first photo, the package had been opened to show the extent of the tear.The second photo shows the package from a top view where the tear occurred 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.H3 other text : see manufacture narration.

• Brand Name: PLEURX PLEURAL CATHETER KIT
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 15084707
• Report Number: 1625685-2022-00077
• Device Sequence Number: 20124159
• Product Code: DWM
• UDI-Device Identifier: 10885403075971
• UDI-Public: (01)10885403075971
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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: Health Professional
• Device Model Number: 50-7000B
• Device Catalogue Number: 50-7000B
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 11/11/2022
• 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