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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ 50 ML CATHETER TIP SYRINGE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ 50 ML CATHETER TIP SYRINGE Back to Search Results
Catalog Number 303553
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2021
Event Type  malfunction  
Manufacturer Narrative
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¿ 50 ml catheter tip syringe experienced foreign matter along the fluid path.The following information was provided by the initial reporter: sterile syringe on opening.It was verified that there was dirt in the nozzle.
 
Manufacturer Narrative
H6: investigation summary: it was reported there was dirt in the nozzle of the syringe.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a syringe out of the packaging blister and inside a plastic bag.The syringe barrel has a brown spot at the nozzle that appears to be embedded degraded resin.No other defects or imperfections are observed.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.A device history record review was completed for provided material number 303553, lot number 0294724.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To mitigate these escapes, the frequency of inspections were increased.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.H3 other text : see h10.
 
Event Description
It was reported that the bd¿ 50 ml catheter tip syringe experienced foreign matter along the fluid path.The following information was provided by the initial reporter: sterile syringe on opening.It was verified that there was dirt in the nozzle.
 
Event Description
It was reported that the bd¿ 50 ml catheter tip syringe experienced foreign matter along the fluid path.The following information was provided by the initial reporter: sterile syringe on opening.It was verified that there was dirt in the nozzle.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-01-31.Investigation summary: it was reported there was dirt in the nozzle of the syringe.To aid in the investigation, one sample in an opened packaging blister and two photos were provided for evaluation by our quality team.The returned sample has two specks of embedded degraded resin.The photos show a syringe out of the packaging blister and inside a plastic bag.The syringe barrel has a brown spot at the nozzle that appears to be embedded degraded resin.No other defects or imperfections are observed.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.A device history record review was completed for provided material number 303553, lot number 0294724.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To mitigate these escapes, the frequency of inspections were increased.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.H3 other text : see h10.
 
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Brand Name
BD¿ 50 ML CATHETER TIP SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12675215
MDR Text Key277731772
Report Number1911916-2021-01098
Device Sequence Number1
Product Code FMF
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,Followup
Report Date 02/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303553
Device Lot Number0294724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2020
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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