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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ASEPTO¿ SCALP INFUSION SET; INTRAVENOUS INFUSION SET

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ASEPTO¿ SCALP INFUSION SET; INTRAVENOUS INFUSION SET Back to Search Results
Catalog Number 388339
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd asepto" scalp infusion set punctured through the packaging unit.The following information was provided by the initial reporter, translated from (b)(6) to english: "extension of the material sealed with the packaging, breaking it.".
 
Event Description
It was reported that the bd asepto¿ scalp infusion set punctured through the packaging unit.The following information was provided by the initial reporter, translated from portuguese to english: "extension of the material sealed with the packaging, breaking it.".
 
Manufacturer Narrative
H6: investigation summary: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 1032509, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the tube was cut and sticking out from the edge of the packaging.Based off the provided photo the engineer was able to verify the reported defect.It was determined that this was an operator error that occurred during the packaging process.H3 other text : see h10.
 
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Brand Name
BD ASEPTO¿ SCALP INFUSION SET
Type of Device
INTRAVENOUS INFUSION SET
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer (Section G)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12407225
MDR Text Key269493666
Report Number9610048-2021-00122
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/19/2021
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 Number388339
Device Lot Number1032509
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/04/2021
Initial Date FDA Received09/01/2021
Supplement Dates Manufacturer Received10/19/2021
Supplement Dates FDA Received11/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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