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

Catalog Number	STP5604
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that particulate matter (pm) was observed within the tubing of a large bore stopcock with extension set.The pm was further described was dark colored debris and was discovered while the customer was flushing the tubing prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information : the device was received for evaluation.A visual inspection via the naked eye was performed which revealed a dark particle visible in the tubing.Additional spectroscopic inspection was performed which determined an irregularly shaped particle 3.9 mm long (as measured in the longest linear dimension) was seen in the tubing.The color of the polymeric particle ranged from dark brown to amber to clear which indicated some degradation may have occurred.It was located 14.25 inches from the stopcock end of the set.The spectroscopy determined the particle was polyvinyl chloride with bis (2-ethylhexyl) phthalate (dehp) plasticizer.The reported condition was verified.The cause of the condition was due to material used in the manufacturing process.However, there are current prevention measures related to this failure mode such as control agreement for applicable components and interplant quality systems, receiving inspections per local and incoming inspection and training (such as assembly sequence, operator certified and setup/verification as well as detection controls which include in-process inspections, periodic checks [functional test] and 100% visual inspection by manufacturing personnel).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 8609572
• Report Number: 1416980-2019-02698
• Device Sequence Number: 2169828
• Product Code: FMG
• UDI-Device Identifier: 00085412476247
• UDI-Public: (01)00085412476247
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/12/2019

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: STP5604
• Device Lot Number: DR18L19022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1