MAUDE Adverse Event Report: ST PAUL DELTEC; GRIPPER

Model Number	22 GAUGE
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical implantable ports|deltec gripper needle separated and embedded under the skin inside port.The nurse went to access portacath and noticed child was scratching site, swab obtained and redressed.On flushing the portacath it was noticed it was leaking.Nurse asked another member of staff to review.She tried to replace the port needle, however the needle had not came off with the gripper and was left inside skin.The plastic gripper section was reported to coma away.The patient was then transferred to another hospital to have the needle removed under general anesthetic.Needle was successfully removed.
Additional Manufacturer Narrative
H6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Units received: sixteen (16) samples were received for evaluation; the returned samples were received decontaminated and inside a plastic fifteen (15) samples received with its original closed package and one (1) sample was received in used condition without its original package.Visual inspection results: it is observed in one sample the needle detached for the base.The complaint is confirmed.Replication of the failure mode: a needle gripper was bent and tested using fixture t98-3198 to proof if the foam assembly could be performed with bent needle condition.Results: the bent samples could not fix in the t98-3198 cavities to perform the foam assembly.The root cause is the product became damaged after it left shm facilities.The cause of the reported problem could not be determined.

• Brand Name: DELTEC
• Common Device Name: GRIPPER
• 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: 11720564
• Report Number: 3012307300-2021-03425
• Device Sequence Number: 3833616
• Product Code: FPA
• UDI-Device Identifier: 10610586015786
• UDI-Public: 10610586015786
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2025
• Device Model Number: 22 GAUGE
• Device Catalogue Number: 21-2714-24
• Device Lot Number: 4002612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 09/22/2021; 06/14/2023
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 03/07/2022; 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR
• Patient Sex: Female