MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (EJ) NEEDLE BM 11GX4 CRADLE; INSTRUMENT, BIOPSY

Model Number	EJM4011
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
This is a report about an open package.According to the customer's report, the package was found to be open before use, and this product was thus not used.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: three photos and one sample were received by our quality team for investigation.Upon visual inspection, it was observed that the package seal was open therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the lot 0001330769 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.A corrective action project was initiated to address this issue.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.H3 other text: see manufacturer here.
Event or Problem Description
This is a report about an open package.According to the customer's report, the package was found to be open before use, and this product was thus not used.

• Brand Name: JAMSHIDI (EJ) NEEDLE BM 11GX4 CRADLE
• Common Device Name: INSTRUMENT, BIOPSY
• 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: 13446347
• Report Number: 1625685-2022-00026
• Device Sequence Number: 4321165
• Product Code: KNW
• UDI-Device Identifier: 10885403464157
• UDI-Public: (01)10885403464157
• 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: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: 10/31/2024
• Device Model Number: EJM4011
• Device Catalogue Number: EJM4011
• Device Lot Number: 0001330769
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/08/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown