MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CAP CHANGE KIT

Catalog Number DYNDC2002A

Device Problem Crack (1135)

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

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported by the customer contact that on (b)(6)23 "transducer and primary tubing connected to cap when found to be cracked along with, microbore tubing and a pall filter connected farther up the line for medication administration.Neither lumen drawing so tpa ordered.Cap and lines changed to replace cracked cap.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 Description

Transducer and primary tubing connected to cap when found to be cracked along with microbore tubing and a pall filter connected farther up the line for medication administration.

• Type of Device: CAP CHANGE KIT
• 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: 17950299
• MDR Text Key: 326065447
• Report Number: 1417592-2023-00414
• Device Sequence Number: 1
• Product Code: OFF
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNDC2002A
• Device Lot Number: 23CBQ551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other