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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD LORD'S ¿ SYRINGE INSULIN SYRINGE

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BD MEDICAL - DIABETES CARE BD LORD'S ¿ SYRINGE INSULIN SYRINGE Back to Search Results
Catalog Number 326668
Device Problems Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd lord's ¿ syringe contained foreign matter and clogged. No serious injury or medical intervention was reported.
 
Manufacturer Narrative
Customer returned (1) loose 1/2cc, 8mm syringe filled with approximately 5 units of a clear liquid inside the barrel. Customer states that middle of the needle was swollen and they couldn't inject. The returned syringe was examined and exhibited some clear, hard material on the surface of the cannula shaft. A small portion of this material was removed from the sample and prepared for ftir spectral analysis. The spectral analysis shows that this material is most likely adhesive. The sample was also tested and some of the liquid in the barrel was able to be expelled without any observed defects. (b)(4) was initiated by the holdrege plant to address adhesive runover unable to perform dhr check for foreign matter on needle and needle clog due to unknown lot number. Based on the samples/photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (adhesive on cannula shaft). Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (needle clog).
 
Event Description
It was reported that bd lord's syringe contained foreign matter and clogged. No serious injury or medical intervention was reported.
 
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Brand NameBD LORD'S ¿ SYRINGE
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7934364
MDR Text Key122809301
Report Number1920898-2018-00763
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number326668
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/04/2018 Patient Sequence Number: 1
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