MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX PRO-VENT 3ML ARTERIAL BLOOD GAS SAMPLING SYRINGE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	G1464J
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.D4.Lot number, expiration date, and h4.Manufacture date are unknown; no information has been provided to date.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.Investigation summary: received for investigation a decontaminated syringe without original packaging.No other components including the filter-pro and needle were returned.Pictures were also attached.The customer stated it was product g1464j lot # unknown.Visual inspection of the used sample showed damage to the shoulder of the syringe barrel (mp805).The noted damage resulted in a hole being present, thus complaint confirmation.In-process, lot acceptance for damages that affect function, are based on inspection, using c=0 (critical) sampling.However, without a provided lot number, review of the maintenance log for the time this production lot ran could not be conducted.Although the complaint was confirmed, the exact contributing factors for the compromised barrel could not be determined.Complaint information will continue to be monitored for any new information and further actions will be taken accordingly.
Event or Problem Description
It was reported that immediately after use, the syringe was found to be damaged.This occurred during infusion at the facility.There was patient involvement, but no harm/adverse event reported.

• Brand Name: PORTEX PRO-VENT 3ML ARTERIAL BLOOD GAS SAMPLING SYRINGE
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20027551
• Report Number: 1217052-2024-00079
• Device Sequence Number: 8600637
• Product Code: JKA
• UDI-Device Identifier: 00351688060184
• UDI-Public: (01)00351688060184
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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