MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP; INSTRUMENT, BIOPSY

Catalog Number DJ4011X

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  malfunction  

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 Description

Dr.Was about to perform a bone aspiration biopsy procedure into his patient.He opened the packaging and noticed a red particle inside the adapter.He requested for a new needle to start and finish the said procedure.(product is available for return.) (b)(6) 2023- ding.-was there any patient involvement? as per global reporting form, no patient involvement.- what was the impact to the patient? as per global reporting form, no patient involvement.- how was the issue resolved? - requested for a new needle.

Manufacturer Narrative

(b)(4) follow-up emdr for device evaluation: three photos and one sample of lot number 0001469760 were provided to our quality team for investigation.The extractor and luer lock were returned with the product.Through visual inspection, it was observed that there is a red particle inside the luer lock adapter; 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 0001469760 was performed and no recorded quality problems or rejections related to this incident were found.The applicable current controls and quality tests were reviewed, and no quality issues or rejections 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 quality team's investigation, it was identified that, the involved component is bought from a supplier and only packaged into the kit, this is not changed chemically or physically in the site, therefore a quality notification was issued to the supplier.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 Description

Dr.Was about to perform a bone aspiration biopsy procedure into his patient.He opened the packaging and noticed a red particle inside the adapter.He requested for a new needle to start and finish the said procedure.(product is available for return.) 29-aug-2023-ding.Was there any patient involvement? as per global reporting form, no patient involvement.What was the impact to the patient? as per global reporting form, no patient involvement.How was the issue resolved? - requested for a new needle.

Manufacturer Narrative

Pr 8715959 follow-up emdr for device evaluation: three photos sample were provided to our quality team for evaluation.During visual inspection, the photos display the product label, confirming the reported product.A red mark appears to be on the surface of the adapter, however due to the quality of the picture it cannot be concluded what it is, if its embedded or not or any other detail; therefore, the reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001469760 was performed and no recorded quality problems or rejections related to this incident were found.The applicable current controls and quality tests were reviewed, and no quality issues or rejections 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.The current manufacturing controls were reviewed: - work instruction calls for the operator to blow debris with compressed air.It specifies that the needle protector is to be removed and both the needle and the protector need to be processed separately to ensure the components are free of particles/debris.- work instruction calls for a visual verification to ensure that the pouch and needle do not have any particles.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 Description

Dr.Was about to perform a bone aspiration biopsy procedure into his patient.He opened the packaging and noticed a red particle inside the adapter.He requested for a new needle to start and finish the said procedure.(product is available for return.) (b)(6) 2023-ding.Was there any patient involvement? as per global reporting form, no patient involvement.What was the impact to the patient? as per global reporting form, no patient involvement.How was the issue resolved? - requested for a new needle.

• Brand Name: JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP
• Type of Device: INSTRUMENT, BIOPSY
• 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: 17691393
• MDR Text Key: 322745847
• Report Number: 9680904-2023-00031
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K171531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DJ4011X
• Device Lot Number: 0001469760
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other