MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ANGIOGRAPHY PACK

Catalog Number	DYNJ04508O
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer, "bd syringe with this subcomponent is unacceptable.Air leaks through, so the customer has been having to toss it".
Additional Manufacturer Narrative
According to the customer, "bd syringe with this subcomponent is unacceptable.Air leaks through, so the customer has been having to toss it".There were no reports of serious injury or intervention.There were no further details for the reported incident.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.

• Common Device Name: ANGIOGRAPHY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093 ; 2249317042
• MDR Report Key: 19041950
• Report Number: 1423395-2024-00383
• Device Sequence Number: 8565248
• Product Code: OEZ
• UDI-Device Identifier: 40195327475544
• UDI-Public: 40195327475544
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNJ04508O
• Device Lot Number: 23LMF893
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown