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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 30ML LS S/C 56 PISTON SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 30ML LS S/C 56 PISTON SYRINGE Back to Search Results
Model Number 302833
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: illegible scale markings reported. To aid in the investigation, three photos were provided for evaluation by our quality team. A photo shows two packaging blisters with what appears to be residues of ink in the sealing area of the top-bottom web of the packaging blisters. One has what appears to be residues of ink in the sealing area of the top-bottom packaging blister. No other defects or imperfections are observed. A device history record review was completed for provided material number 302833, lot number 9029908. The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defects. Verification of the packaging process was performed, including printing and sealing. No conditions were found that could induce the symptoms and the flow of products was good. To date, there have been no other similar events reported for these lots. Investigation conclusion: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed. We will continue monitoring the complaint trend for this product and symptom. With no sample analysis a probable root cause could not be offered.
 
Event Description
It was reported that the syringe 30ml ls s/c 56 experienced illegible scale markings. The following information was provided by the initial reporter: lot no. 9029908: 1 tube has illegible markings on the scale.
 
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Brand NameSYRINGE 30ML LS S/C 56
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 Key12422300
MDR Text Key270631673
Report Number1911916-2021-00930
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number302833
Device Catalogue Number302833
Device Lot Number9029908
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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