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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE Back to Search Results
Catalog Number 328418
Device Problems Detachment Of Device Component (1104); Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: customer returned one loose 1cc syringe. The returned syringe was examined and exhibited a detached cannula. The loose cannula was received inside the barrel. The barrel was examined under the microscope and exhibited adhesive runoff onto the hub with little adhesive inside the hub. The loose cannula was removed from the barrel and exhibited adhesive on the cannula shaft. The sample was not able to be tested for air bubbles or leakage as the cannula was detached from the syringe. Sample will be forwarded to manufacturing (b)(4) on 26jan2018 for further review. As per manufacturing, a review of the device history record was completed for batch# 7241568. All inspections were performed per the applicable operations qc specifications. There were three notifications noted for insufficient adhesive. There were six notifications noted that did not pertain to the complaint. Investigation conclusion: based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (adhesive runoff onto hub). Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (air bubbles and leakage). Probable root cause determined to be misalignment during application of adhesive on the needle lines. When this occurs, adhesive runover onto the hub or possible the cannula may occur. Additionally, adhesive may be inaccurately applied to the rubberized pull wheel on the line, which can additionally transfer adhesive to the cannula during routine use. Capa (b)(4) was initiated by the (b)(4) plant to address 1ml product complaints. On 30jan2018,(b)(4) received one loose 1ml syringe from reported batch# 7241568. All samples were decontaminated per (b)(4) prior to being evaluated. Upon evaluation by (b)(4), it was noted that the sample was received with the cannula detached form the remainder of the syringe and was located within the shield. The sample was visualized under ultraviolet light and noted adhesive along the side of the barrel tip/well and scant traces of adhesive down the barrel core. Additionally, the cannula was also visualized under ultraviolet light and noted small traces of adhesive along the exterior wall of the cannula. Probable root cause likely to be a misalignment of the adhesive nozzle during production of this batch. When this occurs, adhesive can generally be found along the side of the barrel tip, leaving little to no adhesive down the barrel core where affixation of the cannula occurs. This can increase the chances of cannula separation from the remainder of the syringe, either during transport or initial aspiration of insulin. Capa (b)(4) was initiated by the (b)(4) plant to address 1ml product complaints, including cannula separates, and their associated root cause(s). Batch# 7241568 was manufactured prior to implementation of corrective/preventive actions.
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: n/a. A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that a bd insulin syringe with the bd ultra-fine¿ needle detached from the syringe remaining in the vial and then leaked during use. There was no report of injury or medical intervention.
 
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Brand NameBD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7173250
MDR Text Key269771415
Report Number1920898-2017-00431
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328418
Device Lot Number7241568
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/08/2018 Patient Sequence Number: 1
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