MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; CHLORAPREP IN RO TAVR PACK-LF

Model Number	PHS117992003C
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the top of the choloraprep ampoule broke and detached.The broken choloraprep piece fell into the surgical site and was able to be retrieved.New choloraprep was obtained and used for the procedure without further reported incident.The reporting facility indicated that there was no adverse patient impact related to the incident.The sample was reportedly discarded and unavailable to be returned for evaluation.A root cause was not determined at this time.Due to the reported need for medical intervention to retrieve the choloraprep piece from the surgical site, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the top of the choloraprep ampoule broke and detached.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: CHLORAPREP IN RO TAVR PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12464546
• Report Number: 1423395-2021-00040
• Device Sequence Number: 12008555
• Product Code: LRO
• UDI-Device Identifier: 10193489222319
• UDI-Public: 10193489222319
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: PHS117992003C
• Device Catalogue Number: PHS117992003C
• Device Lot Number: 21CDB909
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention