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

Catalog Number	G1461J
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter email unknown.E1.Initial reporter last name 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 when blood was collected from the umbilical cord and placed in a platley with the needle pro activated, all the blood collected flowed out of the needle tip.There was patient involvement, and unknown patient harm.
Additional Manufacturer Narrative
Investigation summary: the affected device was partially returned for evaluation.The provided needle was missing.The sample was disassembled and examined with magnification.Visual inspection revealed a hairline crack present on the syringe barrel running from the.3-.7 ml graduation marks.To evaluate the functionality, colored water was aspirated and then expelled from the syringe through a needle from stock.No leaks were observed from the cracked area.It is possible that the issues observed with the customer were with the needle, however without the actual sample it could not be evaluated.As the manufacturing process is based on manual placement of syringes into blisters, it is likely that the source for the crack is associated with the supplier's manufacturing process.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: PORTEX PROVENT SYRINGE NEEDLE
• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19634990
• Report Number: 1217052-2024-00045
• Device Sequence Number: 18276602
• Product Code: JKA
• UDI-Device Identifier: 00351688060153
• UDI-Public: (01)00351688060153(17)260831(10)4448078
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: 08/31/2026
• Device Catalogue Number: G1461J
• Device Lot Number: 4448078
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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