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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD¿ AN122 IV PUMP SET; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON BD¿ AN122 IV PUMP SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 59011533
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is greater asia.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 foreign matter was found in the bd¿ an122 iv pump set cap.The following information was provided by the initial reporter: "foreign material in an122 pump set (foreign material is discovered in iv set cap).".
 
Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is greater asia.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 foreign matter was found in the bd¿ an122 iv pump set cap.The following information was provided by the initial reporter: "foreign material in an122 pump set (foreign material is discovered in iv set cap).".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-04.H6: investigation summary a device history review was conducted for lot number 2106101.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample was provided to aid in our investigation.Our engineers were able observe a brown foreign material on the adaptor of the device.Compositional testing of the foreign material was able to identify it as polypropylene, the same material that is used to from the body of the adaptor.The most likely cause for this non-conformance is related to the injection process.During the injection molding if the temperature of the machine is outside of the acceptable range it is possible to discolor the raw material.Operations associates are responsible to monitor the calibration of their machines and make not of any observed non-conformances.To prevent a reoccurrence of this event our facility has issued a retraining of the appropriate personnel, and implemented tighter quality controls of the molding process.H3 other text : see h10.
 
Event Description
It was reported that foreign matter was found in the bd¿ an122 iv pump set cap.The following information was provided by the initial reporter: "foreign material in an122 pump set (foreign material is discovered in iv set cap).".
 
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Brand Name
BD¿ AN122 IV PUMP SET
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13063807
MDR Text Key286256563
Report Number2243072-2021-02963
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeKS
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 12/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number59011533
Device Lot Number2106101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2021
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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