MAUDE Adverse Event Report: ST PAUL DELTEC; GRIPPERS NEEDLES

Model Number 21-2766-24

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2020

Event Type  malfunction  

Event Description

Information received a implantable ports|deltec gripper plus needles had an exposed needle that would not retract back into the safety arm.This occurred during use, no patient injury occurred or reported.

Manufacturer Narrative

Investigation completed on a smiths medical implantable ports|deltec gripper plus needles.Four pictures with p/n 21-2766-24 l/n 3967853 were reviewed and found not possible to evaluate problem with safety arm on pictures.Samples were obtained and found when activating the safety arm, the complaint was confirmed.The root cause was believed to be in rev.100 the occurrence for this failure condition ?operator not following the procedure".The engineering process and testing prior to release of product was reviewed and found all product passed at 100% with no discrepancies.Issue confirmed and reported monitoring will be in place on any further issues with product.

Event Description

Investigation completed and summarized in h 10.

• Brand Name: DELTEC
• Type of Device: GRIPPERS NEEDLES
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10977870
• MDR Text Key: 220505668
• Report Number: 3012307300-2020-12238
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586025594
• UDI-Public: 10610586025594
• Combination Product (y/n): N
• PMA/PMN Number: K021999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-2766-24
• Device Catalogue Number: 21-2766-24
• Device Lot Number: 3967853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 12/20/2020
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1