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

Catalog Number	G1460J
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: month and year of event have been provided, but day is unknown.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 during use there was blood leakage with the device.This occurred during use.There was patient involvement, and no patient harm reported.
Additional Manufacturer Narrative
Investigation summary: received one decontaminated 3ml syringe without original packaging for evaluation.Examination of the returned sample showed a hole near the syringe shoulder and the luer slip was chipped.The noted condition was such that it was not possible to conduct a leak test.The lot acceptance for damages that affect function is based on c=0 (critical).Device history record (dhr) information indicates that the lot met acceptance requirements.Based on the results of this investigation the complaint was confirmed.Review of the maintenance logbook for assembly machine (abacus 1) did not reveal any issues pertaining to this type of defect.A quality alert was issued to production to heighten awareness towards this potential issue.Complaint information will continue to be monitored for any new information and further actions will be taken accordingly.

• Brand Name: PORTEX ABG PROVENT
• 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: 20045949
• Report Number: 1217052-2024-00084
• Device Sequence Number: 7896458
• Product Code: JKA
• UDI-Device Identifier: 00351688060146
• UDI-Public: (01)00351688060146(17)261127(10)4449150
• 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): 10/29/2024

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: G1460J
• Device Lot Number: 4449150
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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