MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX PRO-VENT PLUS SYRINGE, NO NEEDLE, FILTER-PRO; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number 4646E

Device Problems Break (1069); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2024

Event Type  malfunction  

Event Description

It was reported that during post-filter calcium control on the extra renal epuration monitor, the gasometer syringe broke off at the sampling site.The tip of the syringe broke off cleanly and remained stuck in the sampling site.The sampling site remained open with the tip inside, resulting in abundant siphoning under pressure from the patient return line.The blood pump had to be stopped urgently, the patient return line clamped and the purification monitor disconnected.Blood restitution could not be performed.Consequences reported: profuse bleeding and requiring the intervention of a physician to change the blood pump's infusion line.Possible reported lot numbers: 4359086 or 4399869.

Manufacturer Narrative

D4: exact lot number, expiration date, udi, and h4: manufacture date are unknown.H3 - other: device has not been returned to date.Device evaluation: no product sample has been provided and the investigation could not confirm whether a quality related issue has resulted in the customer reported problem.The reported problem could not be verified and/or confirmed with confidence; therefore, no further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and take further actions 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: PORTEX PRO-VENT PLUS SYRINGE, NO NEEDLE, FILTER-PRO
• Type of Device: 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: 18678410
• MDR Text Key: 335212988
• Report Number: 1217052-2024-00002
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K952516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4646E
• Device Lot Number: UNCERTAIN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1