MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. ABG-PROVENT 3ML; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	G1459J
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the air was attempted to be removed, but blood leaked out of device.It was discovered that the device was damaged after it was checked.There was patient involvement, and no patient harm/adverse event was reported.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
H3 and h6.Evaluation codes: updated.Received for investigation a used, decontaminated syringe with the tyvek packaging.Visual inspection of the provided sample showed damage to the syringe barrel shoulder.The noted damage resulted in a hole being present, thus complaint confirmation.The device history record (dhr) information for the subassembly lot (cp1707), indicated that a non-conformance associated with the assembly machine was initiated.Among the lot 31,300 pieces were 100 percent inspected, with 31,063 being accepted.It is feasible that a defective sample was missed by the visual inspection.Appropriate actions have been taken since this issue, including changing the tooling on the accumulator.To heighten awareness a quality alert will be forwarded to the production floor.Complaint information will continue to be monitored for any new information and further actions will be taken accordingly.

• Brand Name: ABG-PROVENT 3ML
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19705319
• Report Number: 1217052-2024-00056
• Device Sequence Number: 20777581
• Product Code: JKA
• UDI-Device Identifier: 00351688060139
• UDI-Public: (01)00351688060139(17)270102(10)4454279
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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: G1459J
• Device Lot Number: 4454279
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement 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