MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. ABG PROVENT PLUS, 3ML LL SYRINGE, 23 X 1" NEEDLE, FILTER PRO; SYRINGE, ANTISTICK

Catalog Number	4558PECN
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
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 reportable information becomes available.
Event or Problem Description
It was reported that when the cap was pushed up after drawing blood for arterial blood gas analysis, the blue rubber stopper in the syringe moved, causing blood to flow out of the syringe.There was patient involvement, but no patient harm/adverse event reported.
Additional Manufacturer Narrative
D9.Date returned to mfg: 25-oct-2024 h6.Component code: updated investigation summary: one used and decontaminated 3ml provent syringe with the tyvek packaging loose within a bag was received for investigation.Visual inspection of the returned syringe revealed that the filter (mx868) was missing from the device, thus confirming the complaint.When wetted, the filter acts as a barrier against the fluid leakage past plunger.A missing filter will likely result in leakage.In-process, the supplied filter component is assembled to supplied plunger tip by automation.The rubber plunger tip component b diameter (a spot of contact with stem of the filter) was measured on micro vue and found to be undersized.The b diameter spec is 0.130 in (+/-0.003 in).The actual reading was 0.1238 in.It is possible, that due to this measurement the filter could not be properly assembled to the plunger tip.The lot acceptance for missing components is based on c=0 (critical).No further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.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.

• Brand Name: ABG PROVENT PLUS, 3ML LL SYRINGE, 23 X 1" NEEDLE, FILTER PRO
• 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: 20494909
• Report Number: 1217052-2024-00140
• Device Sequence Number: 3554193
• Product Code: JKA
• UDI-Device Identifier: 20351688039108
• UDI-Public: (01)20351688039108(17)260505(10)4397918
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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 Expiration Date: 05/05/2026
• Device Catalogue Number: 4558PECN
• Device Lot Number: 4397918
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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