MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS INTEGRA PRECISIONGLIDE; SYRINGE, ANTISTICK

Catalog Number	305270
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe integra 3ml w/ndl 25x1 rb plunger rod was broken / damaged.The following information was provided by the initial reporter: material #305270.Lot #2279988.Rcc received a complaint via email.Email(s) attached.Item(s): 305270.Lot(s): 2279988.Date incident occurred: past weekend.Was the patient impacted? if yes, describe: as the customer was injecting, the plunger broke spilling the contents of a complete vial of medicine.Is a sample available? yes & photos attached.Customer request? requests compensation for testoserone and replacement syringe.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - plunger rod broken / damaged.One sample and two photos of a 3ml integra syringe with a 25x1¿ needle (part number 305270) were received for evaluation.The sample was received loose, with all components present, the needle retracted within the syringe, and the stopper cut.One photo showed the labeled package, while the other displayed a loose syringe with the needle and shield attached and the stopper cut.The reported defect could not be confirmed based on the sample or photos provided.The observed condition is within product specifications, and no device-related issue was identified.Furthermore, a device history record review was completed for provided lot number 2279988.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: INTEGRA PRECISIONGLIDE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22001296
• Report Number: 1213809-2025-00333
• Device Sequence Number: 7267013
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: (01)30382903052708(11)221006(17)270930(10)2279988
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• 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): 07/10/2025

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: 305270
• Device Lot Number: 2279988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown