MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD CAP, LG BORE, INT THD, STER; DISPENSER, LIQUID MEDICATION

Catalog Number	H938711008
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/23/2018
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 a black stain was observed on the primary packaging of an exactamix large bore cap.The contamination was discovered before patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The actual device and forty-nine (49) companion samples were returned and an evaluation is complete.A visual inspection with magnification was performed and noted an embedded piece of dark foreign matter on the device packaging of the actual sample.The foreign matter did not come into contact with the device itself.No issues were observed on the 49 companion samples.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported problem was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CAP, LG BORE, INT THD, STER
• Common Device Name: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• MDR Report Key: 7525363
• Report Number: 1416980-2018-02954
• Device Sequence Number: 1176398
• Product Code: KYX
• UDI-Device Identifier: 00085412480060
• UDI-Public: (01)00085412480060
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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 Expiration Date: 11/30/2019
• Device Catalogue Number: H938711008
• Device Lot Number: 1200230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1