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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ EXTENSION SETS; INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ EXTENSION SETS; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 37262E
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 21096075 medical device expiration date: 2024-09-25 device manufacture date: 2021-09-17.Medical device lot #: 21096071 medical device expiration date: 2024-09-23 device manufacture date: 2021-09-17.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 when using the bd smartsite¿ extension sets, the device experienced a mix of product types in a pack.The following information was provided by the initial reporter.The customer stated 30-nov-2021 update: can we ensure this is captured for the investigative team- we have mixed stock of this product that is difficult to distinguish since the packaging is exactly the same.We have had multiple leaks and poor connection with the bad lot.
 
Event Description
It was reported when using the bd smartsite¿ extension sets, the device experienced a mix of product types in a pack.The following information was provided by the initial reporter.The customer stated (b)(6) 2021 update: can we ensure this is captured for the investigative team- we have mixed stock of this product that is difficult to distinguish since the packaging is exactly the same.We have had multiple leaks and poor connection with the bad lot.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-12-31.H6: investigation summary two samples were received for quality investigation.The customer complaint of packaging issue - product issue could not be verified.Although, the male luer adapter connector at the end of the extension sets are different on the two sets, the connection is an approved alternate design, and does not impact the securement and function of the connector.Priming of the extension sets and a simulated infusion test, at a rate of 200 ml/hr was conducted to determine if there was leakage at the male luer connector.There were no issue with leakage observed during the evaluation.A device history record review for model 37262e lot number 21096075 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25sep2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 37262e lot number 21096071 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23sep2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be determined because the failure reported not being replicated.
 
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Brand Name
BD SMARTSITE¿ EXTENSION SETS
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13044197
MDR Text Key283836986
Report Number9616066-2021-52611
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50885403235274
UDI-Public50885403235274
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/11/2022
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 Model Number37262E
Device Catalogue Number37262E
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/31/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/22/2021
Initial Date FDA Received12/20/2021
Supplement Dates Manufacturer Received01/11/2022
Supplement Dates FDA Received01/21/2022
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 Initial
Patient Sequence Number1
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