MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML S/T W/NDL SFTYGLD 25X5/8 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305903
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 1ml s/t w/ndl sftygld 25x5/8 rb syringe needle and body slipped.The following information was provided by the initial reporter: occurred in pediatrics, the syringe needle and the syringe body slipped, resulting in the failure to inject, the sample can be returned, there is no photo, a green claim is required, and a quality investigation report is required.
Event or Problem Description
It was reported that syringe 1ml s/t w/ndl sftygld 25x5/8 rb syringe needle and body slipped.The following information was provided by the initial reporter: occurred in pediatrics, the syringe needle and the syringe body slipped, resulting in the failure to inject, the sample can be returned, there is no photo, a green claim is required, and a quality investigation report is required.
Additional Manufacturer Narrative
H.6.Investigation: one loose disassembled 1ml s/t syringe, a 25g safetyglide needle, and an opened blister package were received.The samples were visually evaluated.The package was confirmed to be from batch #0325431 (p/n 305903).The needle arrived with its safety shield already activated.No damage, molding deformities, or other defects were found in the needle.No defects were observed with the syringe.All components were assembled together with no defects observed.No defects were identified in the samples received.Therefore, corrective actions are not necessary.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: SYRINGE 1ML S/T W/NDL SFTYGLD 25X5/8 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12580769
• Report Number: 1213809-2021-00694
• Device Sequence Number: 11577112
• Product Code: FMI
• UDI-Device Identifier: 00382903059034
• UDI-Public: 00382903059034
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 305903
• Device Lot Number: 0325431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown