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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYRINGE 30ML LL TIP CONV PAK PISTON SYRINGE

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYRINGE 30ML LL TIP CONV PAK PISTON SYRINGE Back to Search Results
Catalog Number 305618
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
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 syringe 30ml ll tip conv pak experienced packaging tears while opening leaving paper shards. The following information was provided by the initial reporter: material no: 305618, batch no: 0307723. Upon opening the sterile package, a big black piece of fuzz/cardboard fell off the top paper liner and fell into the container with the syringes. This is the 5th package of 30 ml syinges that we have found foreign debris.
 
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Brand NameSYRINGE 30ML LL TIP CONV PAK
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11681731
MDR Text Key250451956
Report Number9610847-2021-00156
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,Followup
Report Date 04/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305618
Device Lot Number0307723
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 Received04/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2020
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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