MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. ABG-PROVENT 3ML; SYRINGE, ANTISTICK

Catalog Number	G1464J
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.Investigation summary: the affected device was returned for evaluation.Visual inspection of the sample revealed damage near the shoulder of the syringe, confirming the customer's complaint.Due to the condition of the sample, testing was not conducted.The noted damage resulted in a hole being present, which most likely would cause leakage.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No further action will be taken at this time.Complaint information will continue to be monitored for any new information and further actions taken accordingly.
Event or Problem Description
It was reported that there was a burr on the tip of the syringe.There was no patient involvement and no patient harm/adverse event reported.

• Brand Name: ABG-PROVENT 3ML
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20140415
• Report Number: 1217052-2024-00097
• Device Sequence Number: 12616845
• Product Code: MEG
• UDI-Device Identifier: 00351688060184
• UDI-Public: (01)00351688060184(17)261016(10)4434692
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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: G1464J
• Device Lot Number: 4434692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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