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

Catalog Number 05150149

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms#: (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No non-conformities were visible on the returned 3ml pro-vent luer slip syringes, filter pros or blue stoppers.The customer neither indicated in the complaint description nor provided the actual type of the needle or other device, that was used in conjunction with the syringe to draw the blood.The reported complaint was not confirmed.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.D4: udi information is unknown.G5: premarket (510k) number is unknown.Additional information in h3, h6 and h10.

Event Description

It was reported that the syringes are aspirating air when drawing a sample blood.No patient injury was reported.

• Brand Name: PORTEX ABS BAYER PRO-VENT
• 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16909988
• MDR Text Key: 314976464
• Report Number: 3012307300-2023-05528
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05150149
• Device Lot Number: 4036817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1