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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRESSURE RATED EXT SET BONDED SS 8.5" INTRAVASCULAR ADMINISTRATION SET

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PRESSURE RATED EXT SET BONDED SS 8.5" INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 22003E-07
Device Problems Complete Blockage (1094); Restricted Flow rate (1248)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used. Medical device expiration date: unknown. The reported lot # 10885403242045 was not found for the reported catalog # 22003e-07. The customer's address is unknown. (b)(6) usa has been used as a default. Fda notified?: the initial reporter also notified the fda via medwatch #mw5102826 device manufacture date: unknown. Investigation summary: no product or photo was returned by the customer. It was reported via medwatch report that the user was unable to push and flush any amount of volume through the device. The customer complaint could not be verified due to the product not being returned for failure investigation. A device history record review could not be performed on the provided model because an invalid lot number was provided by the customer. Due to no sample being received, an investigation could not be performed and a root cause could not be determined. Due to an increase in incidents of this failure mode, a trend for this occlusion issue has been identified for this product line, a capa (corrective action preventative action) has been initiated, and a team has been assembled in order to investigate the issue. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported pressure rated ext set bonded ss 8. 5" was clogged/blocked/occluded. The following information was provided by the initial reporter: "not able to push and flush any amount of volume through. ".
 
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Brand NamePRESSURE RATED EXT SET BONDED SS 8.5"
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
MDR Report Key12465081
MDR Text Key271283846
Report Number9616066-2021-52030
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 08/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number22003E-07
Device Catalogue Number22003E-07
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
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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