MAUDE Adverse Event Report: BD IV TUBING SPIKE; SET, I.V. FLUID TRANSFER

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Description

This was seen on a listserv by and (b)(4) staff person and shared with (b)(4).Are any hospitals experiencing disconnections between iv tubing spikes and iv medication bags? we have documented at least 15 patient safety events involving bo primary and secondary iv tubing spikes falling out of iv medication bag ports.The events have occurred with quva fentanyl (with at least one in a douglas medical product bag), sandoz clindamycin, nephron norepinephrine bottles, wg critical care midazolam, bbraun ns 100 ml pab, and bbraun 100 ml addease.There have been no obvious visible defects in any quarantined supplies/drug devices.Evaluation by vendors has not revealed root cause.While these are similar to the events described in the 2/10/2022 acute care (b)(4)medication safety alert, our experiences have been with a different iv tubing vendor and medications bags from unrelated manufacturers.We would greatly appreciate sharing and learning from other health systems that have experienced similar events.(b)(4).

• Brand Name: IV TUBING SPIKE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BD
• MDR Report Key: 14513140
• MDR Text Key: 292963881
• Report Number: MW5109913
• Device Sequence Number: 3
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/25/2022
• 15 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2022
• Patient Sequence Number: 1