MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI NEEDLE BONE MARROW 13GX3.5 ASP; INSTRUMENT, BIOPSY

Model Number	DJ3513X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
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
It was reported by the customer that the needle broke off and was left in the patient's left ilium.Verbatim: the needle broke off in the patient¿s left ilium.The tip which was left in situ measured approximately 7mm x 2mm on xray.The decision was made to leave it in place since attempting to remove it from the hip would be more invasive.This is the second one i am aware of now (the other was (b)(6) of 2021).Patient has remainder of needle in their bone and surgical removal would cause more harm than leaving there.Confidence in provider, product and health system has decreased for this patient and their guardians.
Event or Problem Description
It was reported by the customer that the needle broke off and was left in the patient's left ilium.Verbatim: the needle broke off in the patient¿s left ilium.The tip which was left in situ measured approximately 7mm x 2mm on xray.The decision was made to leave it in place since attempting to remove it from the hip would be more invasive.This is the second one i am aware of now (the other was (b)(6) 2021.Patient has remainder of needle in their bone and surgical removal would cause more harm than leaving there.Confidence in provider, product and health system has decreased for this patient and their guardians.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001429630 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.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.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one sample of lot 0001429630 was provided to our quality team for investigation.Through visual inspection, it was observed that the needle is broken, and the tip of the needle is missing 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 0001429630 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.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 or Problem Description
It was reported by the customer that the needle broke off and was left in the patient's left ilium.Verbatim: the needle broke off in the patient¿s left ilium.The tip which was left in situ measured approximately 7mm x 2mm on xray.The decision was made to leave it in place since attempting to remove it from the hip would be more invasive.This is the second one i am aware of now (the other was (b)(6) 2021.Patient has remainder of needle in their bone and surgical removal would cause more harm than leaving there.Confidence in provider, product and health system has decreased for this patient and their guardians.

• Brand Name: JAMSHIDI NEEDLE BONE MARROW 13GX3.5 ASP
• Common Device Name: 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: 15017626
• Report Number: 9680904-2022-00029
• Device Sequence Number: 2517450
• Product Code: KNW
• UDI-Device Identifier: 10885403087110
• UDI-Public: (01)10885403087110
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171531
• 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,Followup
• Report Date (Section B): 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2026
• Device Model Number: DJ3513X
• Device Catalogue Number: DJ3513X
• Device Lot Number: 0001429630
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 08/19/2022; 08/24/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/19/2022; 08/24/2022
• 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