MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 26X3/8 IB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Needle snapped off syringe when trying to fill cartridge distributor complaint report - international distributor information distributor name: australasian medical & scientific ltd tandem distributor account number: (b)(4).Distributor incident reference number: (b)(4).Country of event: australia date distributor notified: 20 jan 2024 incident information event date: 19 jan 2024 product category: needle issue event details (attach additional pages if needed and do not include the personal data of any individual): 1) caller reported needle snapped off syringe when trying to fill cartridge 2) did the caller insert the needle into the cartridge and encounter fill resistance? - no3) with how many syringes/needles did the caller experience the issue? ¿ one 5) was the syringe/needle reused? - no 6) product with issue - bd 26 g, 3/8" needle, pn 305110 7) is product available for return to bd? ¿ no 8) product lot # - unavailable 9) did issue cause any injury? - no 11) was caller able to fill a cartridge with insulin? ¿ no resolution ¿ replaced needle and was able to fill new one see attached for the rest.
Additional Manufacturer Narrative
(b)(4): initial mdr submission for device evaluation.As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of defect during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10 manufacture narrative.

• Brand Name: NEEDLE 26X3/8 IB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18621856
• Report Number: 1911916-2024-00049
• Device Sequence Number: 2405924
• Product Code: FMI
• UDI-Device Identifier: 30382903051107
• UDI-Public: (01)30382903051107
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2024

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 Catalogue Number: 305110
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 02/01/2024
• 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
• Patient Sex: Unknown