MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TRAY,EPID 20G NYLON, 18G HUSTEAD, PHARM

Catalog Number	PAIN9024
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer contact, on (b)(6) 2023 "the connector had broken off the catheter and the two were no longer connected.A piece of the mcatheter remained in the connector and the catheter that was in the patient was beside the connector" which resulted in breakthrough pain for the patient.The device was said to be in place for 8 hours when the incident was noted.The catheter was connected to a new filter and tubing according to the customer.No additional needle placement was reported.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Catheter became disconnected.

• Common Device Name: TRAY,EPID 20G NYLON, 18G HUSTEAD, PHARM
• 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: 17631345
• Report Number: 1417592-2023-00353
• Device Sequence Number: 12380443
• Product Code: LRO
• UDI-Device Identifier: 10889942448708
• UDI-Public: 10889942448708
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 08/28/2023

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?: No
• Device Catalogue Number: PAIN9024
• Device Lot Number: 22HLA525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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