MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS POWER NEEDLES; PUMP, INFUSION, PCA

Model Number	21-3468-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that air was in the set and air bubbles with intermittent bits of blood return was aspirated."should not have been able to pullback air once the port access set was primed with normal saline".Needle was removed and replaced.No adverse patient effects were reported.
Additional Manufacturer Narrative
Other text: b 3 updated date of event (b)(6) 2021.
Event or Problem Description
17-march-2021: medwatch received.22-march: date of event updated.
Event or Problem Description
Additional information received 8-feb: patient information attributes updated, no patient harm or intervention required.Needle was removed and replaced.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review.Two (2) sample were received for evaluation; the returned samples were received decontaminated without its original packaging.The samples were tested by introducing water with a syringe in order to verify for air in line.No air was detected in the two samples.The complaint was not confirmed.Instruction for use was reviewed to identify any situation that could create the failure mode reported.See below: flush the set.The root cause of the reported issue was not confirmed after sample evaluation the complaint was not confirmed.No corrective actions were implemented since complaint was not confirmed.

• Brand Name: DELTEC GRIPPER PLUS POWER NEEDLES
• Common Device Name: PUMP, INFUSION, PCA
• 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: 11418721
• Report Number: 3012307300-2021-01753
• Device Sequence Number: 11573974
• Product Code: MEA
• UDI-Device Identifier: 10610586033070
• UDI-Public: 10610586033070
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2023
• 2 Devices were Involved in the Event: 1 2

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: 09/20/2025
• Device Model Number: 21-3468-24
• Device Catalogue Number: 21-3468-24
• Device Lot Number: 4042801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 03/22/2021; 07/25/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/20/2021; 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2020
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 112 KG