MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATH PACK

Catalog Number DYNJ57308A

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported the syringe was cracked.When attached to an arterial line, blood was "squirting".To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.Due to the reported problem/issue, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

Crack in syringe.

• Type of Device: CATH PACK
• 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: 18797568
• MDR Text Key: 337260252
• Report Number: 1423395-2024-00108
• Device Sequence Number: 1
• Product Code: OES
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJ57308A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other