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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE 6" SMALL BORE EXTENSION; INTRAVASCULAR ADMINISTRATION SET
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE 6" SMALL BORE EXTENSION; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 385102
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that 2 bd q-syte 6" small bore extensions had a discolored device.The following information was provided by the initial reporter: "when the teacher of the neonatal icu opened the product, he found that the q-syte diaphragm was yellow".
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that 2 bd q-syte 6" small bore extensions had a discolored device.The following information was provided by the initial reporter: "when the teacher of the neonatal icu opened the product, he found that the q-syte diaphragm was yellow".
 
Event Description
It was reported that 2 bd q-syte 6" small bore extensions had a discolored device.The following information was provided by the initial reporter: "when the teacher of the neonatal icu opened the product, he found that the q-syte diaphragm was yellow.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2022-02-17.H6: investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received two opened un-retracted units and three photos.Upon visual inspection, it was found that the septum of the samples had a yellowish color.Your reported defect was confirmed.The material was determined to be a non-foreign, burnt particulate resin.The yellow discoloration is a result of uv exposure in the curing oven during production.Molds are purged between lots to reduce buildup and discoloration; however, one lot can sometimes take up to ten days to produce.The septum is made and supplied by a secondary bd manufacturing facility who is aware of this failure mode.They have been notified of this incidence to increase their awareness to prevent further occurrence of the reported defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
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Brand Name
BD Q-SYTE 6" SMALL BORE EXTENSION
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX  
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13160352
MDR Text Key285766299
Report Number9610847-2021-00633
Device Sequence Number1
Product Code FPA
UDI-Device Identifier30382903851028
UDI-Public30382903851028
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K013621
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 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number385102
Device Catalogue Number385102
Device Lot Number1053403
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2021
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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