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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 60ML SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 60ML SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE Back to Search Results
Model Number 309653
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter email: (b)(6).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1056536.Medical device expiration date: 2026-01-31.Device manufacture date: 2021-02-25.Medical device lot #: 1145183.Medical device expiration date: 2026-01-31.Device manufacture date: 2021-02-25.Investigation summary: it was reported that black speckle markings are present on the syringe.To aid in the investigation, one sample with a packaging blister top web was received for evaluation by our quality team.A visual inspection was performed and the syringe barrel has embedded degraded resin.No other defects or imperfections were 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 309653, lot number 1056536.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 the escapes of the embedded degraded resin defect, the frequency of inspections were increased.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that at least one bd 60ml syringe luer-lok¿ tip experienced scale marking issues.The following information was provided by the initial reporter: we have received the attached complaint for product#309653.Lot# 1056536.There are black speckle markings on packaging and shaft of syringe.
 
Manufacturer Narrative
Correction: this report is a duplicate of mfr 2243072-2021-02864 that was reported for scale marking issue.Mfr 1911916-2021-01204 should be considered cancelled as it did not have a scale marking issue reported by the customer.
 
Event Description
It was reported that at least one bd 60ml syringe luer-lok¿ tip experienced scale marking issues.The following information was provided by the initial reporter: we have received the attached complaint for product#309653.Lot# 1056536.There are black speckle markings on packaging and shaft of syringe.
 
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Brand Name
BD 60ML SYRINGE LUER-LOK¿ TIP
Type of Device
PISTON 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 Key12920276
MDR Text Key285648761
Report Number1911916-2021-01204
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096535
UDI-Public30382903096535
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K110771
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 11/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309653
Device Catalogue Number309653
Device Lot NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2022
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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