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

Catalog Number	305270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe integra 3ml w/ndl 25x1 rb needle pulled out of the hub.The following information was provided by the initial reporter: material # 305270.Batch # 4205749.Verbatim: rcc received a complaint via email.Contact name: (b)(6) contact number: (b)(6) contact email (if available): item(s): 305270 lot(s):4205749 date incident occurred: (b)(6) 2025.Was the patient impacted? yes.If yes, describe: the needle was not able to use needle came out and spring came out.Is a sample available?: yes.Customer request?: product replacement.
Additional Manufacturer Narrative
(b)(6) - supplemental mdr - needle pulled out of hub.One sample of a 3ml integra syringe with a 25x1¿ needle (part number 305270, batch 4205749) was received and evaluated.The spring was missing, the needle was retracted inside the syringe, and the stopper was cut.The reported defect cannot be confirmed from the sample received.The condition observed is acceptable per product specification.Furthermore, a device history record review was completed for provided lot number 4205749.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: 21955575
• Report Number: 1213809-2025-00319
• Device Sequence Number: 9252466
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: (01)30382903052708(11)240723(17)290630(10)4205749
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: Other
• Device Catalogue Number: 305270
• Device Lot Number: 4205749
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown