MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (TJ) NEEDLE BM 11G X3.5 ASP MAC; INSTRUMENT, BIOPSY

Model Number	TJM4011
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported needle bent.Verbatim: needle tip crumbling and losing samples.Per email: we have recently had to change bone marrow biopsy needles from the original jamshidi to the t-handle jamshidi and have encountered some issues with the tips crumpling/ loosing samples.While this is certainly concerning, the purpose of this email today is to inquire if there are technique changes and alternations needed between the two needles.It seems that the t-handle jamshidi require less force, but are there other approaches that can reduce this tip deformation? 10mar2022: customer said 4 occurrences happened on (b)(6), emailed the incidents on march 4 to bd customer service, clarified that needle bent not crumbled.Is waiting on reports concerning patient impact to answer specific questions, said that it will more than likely be within the week.Per email 10mar2022 : just to clarify, is this email in response to a product complaint filed towards the end of (b)(6)? or is this email in response to the technique email sent earlier this month? we have had multiple quality issues with these t handle jamshidis and am unsure which instance you are referring to.As for some general information, we are compiling a list of incident reports where the jamshidi tips are being damaged / samples are being lost.We typically use the original jamshidi but as they have been on back order, the t handle has been the temporary replacement.What was the impact to the patient? multiple biopsies.In some cases the deformed tips have made it possible for samples to be pulled from the needle and get lodged in subcutaneous tissues.In these situations dissection has been required to remove the bone fragment from the patient.What was done to resolve the issue? as this has happened multiple times, physicians have either used the metal insert to pry open the crumpled tip and retrieve the sample or had to repeat the biopsy as the sample was unobtainable.We have been coordinating with stores to get the original jamshidi back in stock as soon as possible, encouraged the submission of incident reports, provided education on pressure and excessive movement; however, this has happened with multiple providers at pmh that do bone marrow biopsies, suggesting technique is not the primary problem.Were they able to complete the procedure successfully with another product? this is the only product available, which is the problem.We were informed that the original was to be back in stock last week; however, they have not yet been stocked.Per provided info "loosing sample" were they able to diagnose it correctly?- in some cases yes, in others no.It depends on the quality of sample/ length of sample for those that got lodged in subcutaneous tissue.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: JAMSHIDI (TJ) NEEDLE BM 11G X3.5 ASP MAC
• 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: 13904678
• Report Number: 1625685-2022-00042
• Device Sequence Number: 14471957
• Product Code: KNW
• UDI-Device Identifier: 10885403044588
• UDI-Public: (01)10885403044588
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 03/14/2022

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 Model Number: TJM4011
• Device Catalogue Number: TJM4011
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/25/2022
• 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