MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX AMNIOCENTESIS TRAY KIT WITH DRUGS; SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY)

Catalog Number A1824-22

Device Problems Material Fragmentation (1261); Failure to Disconnect (2541)

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

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: h4: manufacture date is not available based on the reported lot number.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 Description

It was reported that when de-accessing a patient, when they connect the alaris tubing to the port, the port is getting stuck and breaking/shattering.The customer stated that the incident occurred while in patient use, there was medical intervention and the event caused a potential for harm, but no patient harm presented in this event."difficult to assess, as de-accessing early may put patient at greater risk for clabsi due to increased frequency of accessing.Medical intervention was acquired by the port needing to be de-accessed as a result to correct the issue, and patient re-accessed." event was reported as "ongoing".

• Brand Name: PORTEX AMNIOCENTESIS TRAY KIT WITH DRUGS
• Type of Device: SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17907084
• MDR Text Key: 326040636
• Report Number: 3012307300-2023-09600
• Device Sequence Number: 1
• Product Code: HIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K896031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2008
• Device Catalogue Number: A1824-22
• Device Lot Number: 100678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• 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
• Patient Sequence Number: 1