MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN SYRINGE; SYRINGE, PISTON

Catalog Number	UNKNOWN
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 305110.Batch number#: unknown.It was reported by customer that syringe cracked and insulin spilled out.Verbatim#: rcc received a complaint via email.2) caller reported [syringe cracked and insulin spilled out].3) with how many syringes/needles did the caller experience the issue? - [record number].4) did all issues occur on the same day? ¿ no.Issues occurred: [within past month or so].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) how did the customer resolve the issue? ¿ changed syringe only and successfully filled a cartridge with insulin.Resolution ¿ no further tandem follow up is required.
Additional Manufacturer Narrative
Initial mdr submission with 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.
Additional Manufacturer Narrative
(b)(4) correction: following the submission of the initial mdr, it has been determined that the previously submitted report was sent in error, and the complaint will be cancelled.The associated mdr will be void.

• Brand Name: UNKNOWN SYRINGE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19791743
• Report Number: 2243072-2024-00816
• Device Sequence Number: 12541129
• Product Code: FMF
• UDI-Device Identifier: 30382903051107
• UDI-Public: (01)30382903051107
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K110771
• 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): 06/06/2025

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 06/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown