MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PRO-VENT, LINE DRAW, PULSATOR; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COL

Model Number G1460J

Device Problem Sharp Edges (4013)

Patient Problem Pain (1994)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Other, other text: one used sample was received to perform an investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A visual inspection revealed damage to the shoulder of the syringe barrel near the base of the luer fitting, thus confirming the complaint.No other product anomalies could be observed on the returned sample.The condition of the returned components were such that it was not possible to conduct a leak test; however, the damage to the shoulder of the syringe barrels resulted in a hole to be present, confirming that leakage would most likely occur.As this was a supplied item and the damage to the barrel may have been present as received from the supplier, a supplier notification was issued to the supplier to heighten their awareness to this issue.The reported problem was confirmed but root cause was unable to be determined.Operator of device is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# 617147.

Event Description

It was reported that during use of the product that the staff felt pain on their fingertip caused by burr on the product.No patient or staff injury was reported.

• Brand Name: PRO-VENT, LINE DRAW, PULSATOR
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2jo kudaru, kawaharamachidori,; minneapolis, MN 55442
• MDR Report Key: 15336986
• MDR Text Key: 305544990
• Report Number: 3012307300-2022-17305
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00351688060146
• UDI-Public: 00351688060146
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K952516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/04/2023
• Device Model Number: G1460J
• Device Catalogue Number: G1460J
• Device Lot Number: 3993032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1