MAUDE Adverse Event Report: ST PAUL DELTEC; GRIPPERS NEEDLES

Model Number	21-2766-24
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem Description
Investigation completed and summarized in h 10.

• Brand Name: DELTEC
• Common Device Name: GRIPPERS NEEDLES
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10977870
• Report Number: 3012307300-2020-12238
• Device Sequence Number: 17217113
• Product Code: FPA
• UDI-Device Identifier: 10610586025594
• UDI-Public: 10610586025594
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Expiration Date: 04/22/2025
• 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 Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/20/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1