MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS NEEDLE BONE MARROW 15G ADJ LEN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	DIN1515X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Local Reaction (2035)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: the lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.H10: annex e: e172002 - cellulitis, e1901 - bacterial infection.H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that on (b)(6) 2025, a bone marrow aspiration procedure was performed.Subsequently, on (b)(6) 2025, the patient presented erythema, pain, and heat at the aspiration puncture site.Given these findings, treatment with cephalothin was initiated to treat the bacterial infection.It was further reported that on (b)(6) 2025, the lesion was poorly evolving, and the size increased to approximately 4x3cm.It was also mentioned that greater erythema, edema, and localized induration, blackish coloration in the center of the lesion, accompanied by an increased in local temperature, without the presence of fluid or pus (seropurulent secretion) was observed.An ultrasound study of the right iliac crest and gluteus showed inflammatory changes in the puncture site, with no evidence of collections; therefore, cephalothin antibiotic medication was suspended after 10 days of use and therapy with vancomycin was started to continue bacterial infection treatment.However, a purulent abscess (pus) developed which was drained and cultured.On (b)(6) 2025, the treatment was successful with clinical improvement of the wound, so the patient was giving cefepime for 10 days and 14 days of vancomycin to complete treatment for the bacterial infection.
Event or Problem Description
It was reported that on (b)(6) 2025, a bone marrow aspiration procedure was performed.Subsequently, on (b)(6) 2025, the patient presented erythema, pain, and heat at the aspiration puncture site.Given these findings, treatment with cephalothin was initiated to treat the bacterial infection.It was further reported that on (b)(6) 2025, the lesion was poorly evolving, and the size increased to approximately 4x3cm.It was also mentioned that greater erythema, edema, and localized induration, blackish coloration in the center of the lesion, accompanied by an increased in local temperature, without the presence of fluid or pus (seropurulent secretion) was observed.An ultrasound study of the right iliac crest and gluteus showed inflammatory changes in the puncture site, with no evidence of collections; therefore, cephalothin antibiotic medication was suspended after 10 days of use and therapy with vancomycin was started to continue bacterial infection treatment.However, a purulent abscess (pus) developed which was drained and cultured.On (b)(6) 2025, the treatment was successful with clinical improvement of the wound, so the patient was giving cefepime for 10 days and 14 days of vancomycin to complete treatment for the bacterial infection.
Additional Manufacturer Narrative
H10: manufacturing review: a review of the internal manufacturing device record and raw material history files for the reported lot number 0001559853 was performed and no recorded quality problems or rejections related to this incident were found.It was confirmed that procedural and functional requirements needed for its release were met.H10: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.H10: b5 (describe event or problem), g4 (date received by manufacturer), g7 type or report - follow up# 1), h2 (correction and additional information).H11: h6: annex g (component code), h6 (type of investigation, investigation findings, and investigation conclusions).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that on (b)(6) 2025, a bone marrow aspiration procedure was performed.Subsequently, on (b)(6) 2025, the patient presented erythema, pain, and heat at the aspiration puncture site.Given these findings, treatment with cephalothin was initiated to treat the bacterial infection.It was further reported that on (b)(6) 2025, the lesion was poorly evolving, and the size increased to approximately 4x3cm.It was also mentioned that greater erythema, edema, and localized induration, blackish coloration in the center of the lesion, accompanied by an increased in local temperature, without the presence of fluid or pus (seropurulent secretion) was observed.An ultrasound study of the right iliac crest and gluteus showed inflammatory changes in the puncture site, with no evidence of collections; therefore, cephalothin antibiotic medication was suspended after 10 days of use and therapy with vancomycin was started to continue bacterial infection treatment.However, a purulent abscess (pus) developed which was drained and cultured.On (b)(6) 2025, the treatment was successful with clinical improvement of the wound, so the patient was giving cefepime for 10 days and 14 days of vancomycin to complete treatment for the bacterial infection.
Additional Manufacturer Narrative
H11: e1 (initial reporter facility name), g3 (date received by manufacturer), g6 type or report - follow up# 2), h2 (correction and additional information).Section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: ILLINOIS NEEDLE BONE MARROW 15G ADJ LEN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 22015451
• Report Number: 9680904-2025-00009
• Device Sequence Number: 9412180
• Product Code: FMI
• UDI-Device Identifier: 10885403087042
• UDI-Public: (01)10885403087042(11)240319(17)290216(10)0001559853
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K930217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DIN1515X
• Device Lot Number: 0001559853
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 07/03/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/27/2025; 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown