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

Model Number	50-7280
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
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 multiple issues re access tip.Verbatim: /omitted/ advised me to reach to you regarding a possible product defect we discovered in the (b)(6) lab yesterday morning.This product is manufactured in the (b)(4) and we made /omitted/ and /omitted/ aware of this observation yesterday afternoon.I was made aware of this yesterday at 9:46 am (central) by our lab tech, /omitted/.Observations (n=1): the dilator on the lockable access tip has a molding defect which is a.046¿ wide groove located.083¿ from the distal end of the tip.The dilator on the lockable access tip has a molding defect which is a thicker section of plastic located.377¿ from the distal end of the tip.This section of the dilator should gradually taper down to the distal end of the tip.The dilator on the lockable access tip has a molding defect which is a deflected/off-center dilator.Defect was discovered after performing a leak test and discovered that this part could not provide an air tight seal.
Additional Manufacturer Narrative
(b)(4).Follow-up emdr for device evaluation: three samples of lot 0001403586 and one presentation with different photos were provided to our quality team for investigation.Through visual inspection, deformations on the surface of the samples observed; therefore, the reported failure could be verified.A review of the internal manufacturing device records and raw material history files for the lot 0001403586 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections throughout 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.However, during the investigation it was observed that dispensing excess cyclohexanone could cause some deformations to the component.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 manufacturer here.
Event or Problem Description
Observations (n=1): the dilator on the lockable access tip has a molding defect which is a.046¿ wide groove located.083¿ from the distal end of the tip.The dilator on the lockable access tip has a molding defect which is a thicker section of plastic located.377¿ from the distal end of the tip.This section of the dilator should gradually taper down to the distal end of the tip.The dilator on the lockable access tip has a molding defect which is a deflected/off-center dilator.Defect was discovered after performing a leak test and discovered that this part could not provide an air tight seal.Leakage.

• Brand Name: PLEURX CATHETER ACCESS KIT
• 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 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13025455
• Report Number: 9680904-2021-00112
• Device Sequence Number: 1893823
• Product Code: DWM
• UDI-Device Identifier: 10885403185694
• UDI-Public: (01)10885403185694
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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: Other
• Device Expiration Date: 02/09/2024
• Device Model Number: 50-7280
• Device Catalogue Number: 50-7280
• Device Lot Number: 0001403586
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown