MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number FNC3220

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was received for evaluation.A visual inspection was performed and two pinch marks were noted at the tubing.The reported condition of particulate matter (pm) was not observed in the returned set and therefore could not be verified.The customer could have misunderstood the pinched tubing as pm.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The sample was found to be out of specification, however, as an underwater pressure leak test was performed and a leak was observed at the pinched tubing.This additional issue is addressed in related (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that particulate matter (pm) was observed within the tubing of a clearlink system continue-flo blood/solution infusion set.The pm was further described as a black mark.The pm contaminant was discovered during preparation and before patient use.There was no patient involvement.No additional information is available.

• Brand Name: CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7571199
• MDR Text Key: 110180515
• Report Number: 1416980-2018-03416
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412091990
• UDI-Public: (01)00085412091990
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: FNC3220
• Device Lot Number: SR17K01044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1