MAUDE Adverse Event Report: CAREFUSION, INC LOCKABLE DRAINAGE LINE; APPARATUS, SUCTION, PATIENT CARE

Catalog Number	50-7245A
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Mat# 50-7245a lot# unknown.It was reported by customer that three of these were contaminated.Verbatim: rcc received a complaint via email.Email(s) attached.Regarding order confirmation 5008899844, po 12723762, item 50-7245a, drn ln lk pleurx peritx three of these were contaminated.
Additional Manufacturer Narrative
Pr 9024666 initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a1801.Patient problem code: f24 h3 other text : see manufacture narration.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: four photos samples were received by our quality team for investigation.Upon visual inspection, it was observed that there is a yellow substance in the surface of the locking access dilator component.Based on the visual inspection performed, the failure mode could be 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.
Event or Problem Description
Mat# 50-7245a lot# unknown.It was reported by customer that three of these were contaminated.Verbatim: rcc received a complaint via email.Email(s) attached regarding order confirmation (b)(4), po 12723762, item 50-7245a, drn ln lk pleurx peritx three of these were contaminated.

• Brand Name: LOCKABLE DRAINAGE LINE
• 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: 17984855
• Report Number: 9680904-2023-00038
• Device Sequence Number: 7531154
• Product Code: DWM
• UDI-Device Identifier: 10885403502385
• UDI-Public: (01)10885403502385
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/01/2023

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: Health Professional
• Device Catalogue Number: 50-7245A
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/01/2023
• 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
• Patient Sex: Unknown