MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER, IV, SURESITE AUTO, 22G X 1.00"

Catalog Number	DYNA22100
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the customer contact that on 12/5/23, "the iv nurse placed the catheter as she normally does, needle was retracted and the line was flushed well.She taped the catheter and hub down in standard fashion and then noticed there was some blood.She peeled back some of the tape to check the site and the plastic catheter had broken off into the patient, leaving the hub and iv extension/ns flush disconnected".It was reported that the piece was not able to be removed and the patient was "transferred to the emergency room where he was scanned and eventually told the location of the catheter was not concerning enough to surgically remove and he was sent home".A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Iv catheter broke off into the patient.

• Common Device Name: CATHETER, IV, SURESITE AUTO, 22G X 1.00"
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18426914
• Report Number: 1417592-2023-00531
• Device Sequence Number: 7771551
• Product Code: FOZ
• UDI-Device Identifier: 10193489140071
• UDI-Public: 10193489140071
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2024

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?: No
• Device Catalogue Number: DYNA22100
• Device Lot Number: 27823080007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown