MAUDE Adverse Event Report: ST PAUL IMPLANTABLE PORTS DELTEC; GRIPPERS

Model Number 19 GUAGE

Device Problem Separation Failure (2547)

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

Event Date 03/15/2021

Event Type  malfunction  

Event Description

Information received a smiths medical implantable ports|deltec gripper plus needles malfunctioned.Reported the joint of the needle broke off during removal, thus no function of the safety mechanism possible.No injury occurred.

Manufacturer Narrative

Other, other text: twelve pictures were attached and it could be seen that the safety mechanism was broken and the needle was out of it.The complaint is confirmed.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: IMPLANTABLE PORTS DELTEC
• Type of Device: GRIPPERS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11690942
• MDR Text Key: 248451026
• Report Number: 3012307300-2021-03287
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19 GUAGE
• Device Catalogue Number: 21-2768-24
• Device Lot Number: 4027302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1