MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-2735-24
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was breakage of delivery.No additional information.
Additional Manufacturer Narrative
Other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Four shelf cartons of thirty-six samples were returned inside of a plastic bag which it is not their original packaging.Visual inspection did not observe any damage or bent condition of the pouches inside of the self carton, however out of the shelf cartons were observed and received damaged.The shelf carton is packaged inside of transit cartons to protect from damage, and all transit cartons have corner protection with a mesh to ensure products aren't damaged while transported.It was concluded that failure reported could not be reproduced in the packaging process; therefore the damage was after the product left manufacturing facilities.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

• Brand Name: DELTEC GRIPPER NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14207495
• Report Number: 3012307300-2022-06961
• Device Sequence Number: 11851675
• Product Code: FPA
• UDI-Device Identifier: 10610586015861
• UDI-Public: 10610586015861
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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: Health Professional
• Device Model Number: 21-2735-24
• Device Catalogue Number: 21-2735-24
• Device Lot Number: 4235343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown