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

Catalog Number DYNA22100

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/05/2023

Event Type  Injury  

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It was reported by the customer contact that on 12/5/23, "the iv nurse placed the catheter as she normally does, needle was retracted and the line was flushed well.She taped the catheter and hub down in standard fashion and then noticed there was some blood.She peeled back some of the tape to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 Description

Iv catheter broke off into the patient.

• Type of Device: 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
• MDR Text Key: 331808971
• Report Number: 1417592-2023-00531
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other