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

Model Number	21-2764-24
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer contact phone number: (b)(6).
Event or Problem Description
It was reported that the needle broke apart in the area within the hinge of the deltec gripper plus.More specifically this was observed when pulling and releasing the safety mechanism.The product problem did not cause or contribute to any adverse health effects for the patient.
Additional 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: DELTEC
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11672302
• Report Number: 3012307300-2021-03174
• Device Sequence Number: 16934180
• Product Code: FPA
• UDI-Device Identifier: 10610586025570
• UDI-Public: 10610586025570
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: Health Professional
• Device Expiration Date: 09/01/2024
• Device Model Number: 21-2764-24
• Device Catalogue Number: 21-2764-24
• Device Lot Number: 3862640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1