MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS; STOPCOCK, I.V. SET

Catalog Number	2C6251
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing of an unspecified number of four-way large bore stopcock extension sets were cut.The tubing of the set was diagonally cut approximately ½ inch.It was further reported that proximal to the first cut was another cut approximately ¼ inch and proximal to the second cut were two parallel cuts approximately ½ inch each.The cuts were discovered during an unspecified process step.There were no infection control issues reported and there was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• MDR Report Key: 8930570
• Report Number: 1416980-2019-04629
• Device Sequence Number: 2768829
• Product Code: FMG
• UDI-Device Identifier: 00085412028934
• UDI-Public: (01)00085412028934
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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: Other
• Device Catalogue Number: 2C6251
• Device Lot Number: DR19C13022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1