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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 20ML LL S/C 48 PISTON SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 20ML LL S/C 48 PISTON SYRINGE Back to Search Results
Catalog Number 302830
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: it was reported by the medical professional, the syringe did not have any numbers or markings. To aid in the investigation, three samples in sealed packaging blisters and one photo was provided for evaluation by our quality team. A visual inspection was performed and the scale printing is missing on the samples received. No other defects or imperfections were observed. The photo provided shows a packaging blister with a syringe that appears to have no scale marking. From the photo it is difficult to be certain, the scale marking could be at the bottom side of the syringe and may not be seen. This defect could occur if there was a jam during the printing process inducing the missing scale markings. A device history record review was completed for provided material number 302830, lot number 1113409. The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect. Investigation conclusion: based on the investigation and with the returned 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. Root cause description: probable root cause. It could be possible that the printing drum got misaligned inducing the scale printing missing. Verification of the syringe printing process was performed. Settings were correct, printing pad was properly adjusted. Flow of products was good. Rationale: capa not required at this time.
 
Event Description
It was reported that syringe 20ml ll s/c 48 was missing scale markings. The following information was provided by the initial reporter: it was reported by the medical professional, the syringe did not have any numbers or markings.
 
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Brand NameSYRINGE 20ML LL S/C 48
Type of DevicePISTON 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 Key12391912
MDR Text Key268932736
Report Number1911916-2021-00896
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
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
Report Date 08/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302830
Device Lot Number1113409
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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