MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI NEEDLE BONE MARROW BMB- DJ4008X; INSTRUMENT, BIOPSY

Model Number	DJ4008X
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	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
This is a report about package seal integrity.According to the customer's report, there was a sealing defect on the package.The package was opened.It was found before use.The customer doesn't reported any other defect other than package was opened.Bdj received an actual unopened sample and confirmed the sealing of package was opened at the length of 5 cm.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one physical sample was received by our quality team for investigation.Upon visual inspection, it was observed that the package is opened on the right side therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for reported lot 0001281025 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.While we were not able to identify a direct issue, a corrective action project has been initiated to further investigate and address this failure.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
This is a report about package seal integrity.According to the customer's report, there was a sealing defect on the package.-the package was opened.-it was found before use.-the customer doesn¿t reported any other defect other than package was opened.

• Brand Name: JAMSHIDI NEEDLE BONE MARROW BMB- DJ4008X
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 11649361
• Report Number: 9680904-2021-00042
• Device Sequence Number: 3355944
• Product Code: KNW
• UDI-Device Identifier: 10885403087134
• UDI-Public: (01)10885403087134
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 12/11/2023
• Device Model Number: DJ4008X
• Device Catalogue Number: DJ4008X
• Device Lot Number: 0001281025
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 04/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other