MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ABS PRO-VENT; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	G1460J
Medical Device Problem Codes	Break (1069); 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
Event or Problem Description
It was reported that the tip of the syringe broke and blood leaked out.This happened twice in a row.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3: day of event is unknown.D4: lot number, expiration date and udi information is unknown.H4: manufacturing date is unknown.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
D4.Primary udi number: (b)(4).G1.Mfg contact office address 1: (b)(6).Investigation summary: a bag containing one used, decontaminated 3ml provent syringe was received for evaluation.No original packaging was present.Customer stated the product was g1460j, but no lot number was provided.The needle-pro/ needle were not included.Visual inspection of the returned sample revealed that the luer fitting was visibly bent, thus complaint confirmation.The sample was compared to the reference chart which demonstrates the visual acceptable limit for a slightly bent syringe luer.The sample was found to be outside of the acceptable range for bent luers.Further assessment using magnification revealed the luer was bent so severely that it created a stress mark at the base.To determine if the bent luer would affect the syringe's functional ability, a combo leak test was conducted.This procedure tests for liquid leakage between mating luers.A stock needle was attached to the returned syringe and leakage was observed from the compromised luer.While the damage was confirmed, it was not possible to determine the actual cause.A possible source of this defect could have been excessive force during packing and/or handling.The overall length of the assembled components (syringe, needle-pro long and 1.25 needle) may have acted as leverage, creating a fulcrum point at the location of the mating luers.Because the lot number was unknown, no further evaluation could be performed at this time.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.

• Brand Name: PORTEX ABS PRO-VENT
• 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: 20042902
• Report Number: 1217052-2024-00083
• Device Sequence Number: 7896365
• Product Code: JKA
• UDI-Device Identifier: 00351688060146
• UDI-Public: (01)00351688060146
• 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): Unknown
• 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
• 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: 08/02/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/29/2024
• 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