MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS NEEDLE BONE MARROW 18G ADJ LEN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	DIN1518X
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Where during the control a blue plastic debris was noticed.He observed the presence of "blue" colored particles (inside the individual packaging) which would appear to be "debris" of blue plastic from the device.The manufacturer is required to justify the presence and harmlessness of these "debris".
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: (b)(4).Patient problem code: (b)(4).
Event or Problem Description
Where during the control a blue plastic debris was noticed.He observed the presence of "blue" colored particles (inside the individual packaging) which would appear to be "debris" of blue plastic from the device.The manufacturer is required to justify the presence and harmlessness of these "debris".
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: five photos of lot 0001360956 were provided to our quality team for investigation.Through visual inspection, it was observed that there is a blue particle inside the package, verifying the reported failure.A review of the internal manufacturing device records and raw material history files for reported lot 0001360956 was performed and no recorded quality problems or rejections related to this incident were found, all procedural and functional requirements for product release have been met.During the investigation performed, it was verified that the ionization air equipment is implemented to blow the units on the manufacturing line after assembly, to minimize the occurrence of this failure mode.The preventive maintenance of the equipment was reviewed through the preventive maintenance form, it was confirmed that the corresponding corrective maintenance was carried out and no problems were found during it.Based on the results of the investigation we are able to identified inconsistency when following the inspection procedure in the packaging area that indicates that the pouch must be shaken to ensure that it is free of particles.Manufacturing personnel have been notified of this incident and additional training was provided regarding the proper inspection method to ensure the package is free of particles.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.

• Brand Name: ILLINOIS NEEDLE BONE MARROW 18G ADJ LEN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 13670307
• Report Number: 9680904-2022-00015
• Device Sequence Number: 19998462
• Product Code: FMI
• UDI-Device Identifier: 10885403087073
• UDI-Public: (01)10885403087073
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K930217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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 Expiration Date: 04/13/2025
• Device Model Number: DIN1518X
• Device Catalogue Number: DIN1518X
• Device Lot Number: 0001360956
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/06/2022
• 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