MAUDE Adverse Event Report: CAREFUSION, INC CHIBA NEEDLE 20G X 15CM 10/CS; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	CHI2015
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a050401, patient problem code: f26.H10 : d4 (expiration date: 04/2026).
Event or Problem Description
It was reported by customer that they are using chi2015 and when hooking up extension tubing it doesn't lock onto the set and leaks.Verbatim: rcc received a complaint via email.Customer is using chi2015 and when hooking up extension tubing it doesn't lock onto the set and leaks.Material#chi2015, lot#0001535280.When was issue detected? - prior to use.Customer response on (b)(6) 2024.What was the impact to the patient? impact to patient would be the potential for harm.Needle placement is very specific and due to the force required to attach a syringe or extension set, the potential for internal body system injury is significant.How was the issue resolved? ordering a different needle that does not have a square hub from a different manufacturer.Was the defective product used on the patient? yes, multiple uses from multiple lots with noted difficulty by providers with leaking of hub and strain with connection to syringe/extension set.Is there a physical sample available showing the reported issue? yes, this issue has been demonstrated to representative and remaining stock has been pulled from procedure space.Customer response 1 on (b)(6) 2024.Unfortunately, i can't give you all of the other lot numbers associated with the leakage issue.I have one other lot number that i can provide and will send it later this afternoon when i'm on site at pain clinic.(the leakage issue was brought to our attention recently.Prior to that, we were not aware of the issue and did not record all the lot numbers that we ordered.) customer response 2 on (b)(6) 2024.I hope all is well! the lot numbers are 0001535280 and 0001418206.
Additional Manufacturer Narrative
H10: pr 10938318 follow-up emdr for device evaluation: four physical samples, one photo and one video were received by our quality team for investigation.Upon visual inspection, no anomalies were observed.No flash, deformation, contamination or break was noted to the hub.The hubs were inspected dimensionally and were found within specification against the applicable document.During the visual evaluation of the photo, no anomalies were noted to the hub.The video shows a chiba needle connected to an extension line with luer connection.There is liquid leakage at the connection point between the extension line and the hub of the chiba needle.No other anomalies were noted.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001418206 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.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 by customer that they are using chi2015 and when hooking up extension tubing it doesn't lock onto the set and leaks.Verbatim: rcc received a complaint via email.Email(s) attached.Customer is using chi2015 and when hooking up extension tubing it doesn't lock onto the set and leaks material#chi2015 lot#0001535280 when was issue detected? - prior to use customer response on (b)(6) 2024 what was the impact to the patient? impact to patient would be the potential for harm.Needle placement is very specific and due to the force required to attach a syringe or extension set, the potential for internal body system injury is significant.How was the issue resolved? ordering a different needle that does not have a square hub from a different manufacturer.Was the defective product used on the patient? yes, multiple uses from multiple lots with noted difficulty by providers with leaking of hub and strain with connection to syringe/extension set is there a physical sample available showing the reported issue? yes, this issue has been demonstrated to representative and remaining stock has been pulled from procedure space customer response 1 on (b)(6) 2024 unfortunately, i can't give you all of the other lot numbers associated with the leakage issue.I have one other lot number that i can provide and will send it later this afternoon when i'm on site at pain clinic.(the leakage issue was brought to our attention recently.Prior to that, we were not aware of the issue and did not record all the lot numbers that we ordered.).

• Brand Name: CHIBA NEEDLE 20G X 15CM 10/CS
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• 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: 20523486
• Report Number: 9680904-2024-00024
• Device Sequence Number: 20829024
• Product Code: GAA
• UDI-Device Identifier: 10885403088872
• UDI-Public: (01)10885403088872
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: 04/26/2026
• Device Catalogue Number: CHI2015
• Device Lot Number: 0001418206
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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