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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE Back to Search Results
Model Number 328418
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/29/2021
Event Type  malfunction  
Manufacturer Narrative
Samples were received and an investigation was performed. This is the 1st complaint for the reported lot number. A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot. Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time. Customer returned (1) 1cc, 8mm, 31g syringe in an open poly bag with the shelf carton from lot # 0114733. Customer states that the needle was bent. The returned syringe was examined and exhibited a bent cannula and a deformed barrel tip. A review of the device history record was completed for batch# 0114733. All inspections were performed per the applicable operations qc specifications. There was one (1) notification [(b)(4) ] noted that did not pertain to the complaint. The customer states that the needle was bent. Photo of the sample found that the cannula & barrel tip are bent and difficult to determine if the sample shown in the photo has a dull or blunt point on the cannula. This machine inspects for missing cannula, cannula height, point quality, zero line placement, and uv adhesive. It also supplies lube to the cannula, features two lumen blows, assembles the shield to the barrel/cannula assembly, and detects for missing shields. Reviewed dhr records, logbooks & maintenance history from sap did not find any potential causes/ adjustments to the process. Investigation conclusion: based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Root cause description: no exact root cause determined. Rationale: based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
 
Event Description
It was reported syringe 1. 0ml 31ga 8mm ufii 10bag 500cs was damaged. The following information was provided by the initial reporter: it was reported by the consumer the needle was bent and the housing holding the needle was bent.
 
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Brand NameSYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS
Type of DevicePISTON 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12073002
MDR Text Key259027131
Report Number1920898-2021-00696
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908418034
UDI-Public00382908418034
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328418
Device Catalogue Number328418
Device Lot Number0114733
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2020
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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