MAUDE Adverse Event Report: CAREFUSION, INC ECONOMY SOFT TISSUE BIOPSY TRAY; TRAY, SURGICAL, NEEDLE

Catalog Number	4380
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 4380 batch#: 0001525049.It was reported by customer that hair found inside of packaging.Verbatim: rcc received a complaint via email.Email(s) attached.Hair found inside of packaging.Injuries or adverse event: no.Per follow-up- looks like the package is not open.See attached picture.
Additional Manufacturer Narrative
(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a1801.Patient problem code: f27.
Event or Problem Description
It was reported by customer that hair found inside of packaging.Verbatim.Rcc received a complaint via email.Email(s) attached.Hair found inside of packaging.Injuries or adverse event: no.Are any samples available for return? yes.Per follow-up- looks like the package is not open.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one photo sample was received by our quality team for investigation.Upon visual inspection of the photo, hair was observed potentially be adhered to the swabstick; 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 0001525049 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.Manufacturing personnel have been notified of this incident and awareness training was provided.A quality notification will be sent to the supplier for 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.

• Brand Name: ECONOMY SOFT TISSUE BIOPSY TRAY
• Common Device Name: TRAY, SURGICAL, NEEDLE
• 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: 18103621
• Report Number: 1625685-2023-00107
• Device Sequence Number: 5697906
• Product Code: FSH
• UDI-Device Identifier: 10885403108563
• UDI-Public: (01)10885403108563
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K813338
• 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): 01/17/2024

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 4380
• Device Lot Number: 0001525049
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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