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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION IN-LINE BURETROL EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION IN-LINE BURETROL EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number EMC2421P
Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an in-line buretrol extension set had a hair (eyelash) sealed within the sterile outer wrapper.This issue was identified prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to d9, h3, h4 and h6.H10: the device was received for evaluation.A visual inspection was performed which observed a hair inside the pouch.The reported condition was verified.The cause of the reported condition is manufacturing process related.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.
 
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Brand Name
IN-LINE BURETROL EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11786845
MDR Text Key249469949
Report Number1416980-2021-02718
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/06/2021
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
Device Operator Other
Device Catalogue NumberEMC2421P
Device Lot Number20H26T516N
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2021
Initial Date Manufacturer Received 04/12/2021
Initial Date FDA Received05/06/2021
Supplement Dates Manufacturer Received06/04/2021
Supplement Dates FDA Received06/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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