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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 Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2021
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 20119637. Medical device expiration date: 11/20/2020. Device manufacture date: 11/13/2021. Medical device lot #: 20119619. Medical device expiration date: 11/17/2020. Device manufacture date: 11/19/2021. Medical device lot #: 20119636. Medical device expiration date: 11/20/2020. Device manufacture date: 11/20/2020. Medical device lot #: 20109559. Medical device expiration date: 10/19/2020. Device manufacture date: 10/20/2021. Medical device lot #: 20109560. Medical device expiration date: 10/19/2020. Device manufacture date: 10/21/2021. Medical device lot #: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: it was reported that the tubing came apart on the set. The sets were examined for defects and abnormalities. The samples were connected to a cut off syringe tip to check that the fluid path is in an activated position/open when connected to a syringe. The samples were then attempted to be flushed with water using a 10ml bd syringe to confirm an open fluid path. 28 samples from lot 20119637 were returned by the customer. The fluid paths of 11 samples were open and those samples were able to be flushed. The failure was unable to be replicated in these samples. The fluid paths of 17 samples were not open and were unable to be flushed. The customer complaint can be verified in these samples. 4 samples from lot 20119619 were returned by the customer. The fluid paths of 3 samples were open and those samples were able to be flushed. The failure was unable to be replicated in these samples. The fluid path of 1 sample was not open and was unable to be flushed. The customer complaint can be verified in these samples. 9 samples from lot 20119636 were returned by the customer. The fluid paths of 4 samples were open and those samples were able to be flushed. The failure was unable to be replicated in these samples. The fluid paths of 5 samples were not open and were unable to be flushed. The customer complaint can be verified in these samples. 1 sample from lot 20109559 was returned by the customer. The sample was then attempted to be flushed with water using a 10ml bd syringe to confirm an open fluid path. The fluid path of the sample was open and the sample was able to be flushed. The failure was unable to be replicated in this sample. 2 samples from lot 20109560 were returned by the customer. The fluid path of one sample was open and that sample was able to be flushed. The failure was unable to be replicated in that sample. The fluid path of one sample was not open and was unable to be flushed. The customer complaint can be verified in that sample. 7 samples from an unspecified lot were returned by the customer. The fluid paths of 4 samples were open and those samples were able to be flushed. The failure was unable to be replicated in these samples. The fluid paths of 3 samples were not open and were unable to be flushed. The customer complaint can be verified in these samples. A device history record review for model 22003e-07 lot number 20119637 was performed. The search showed that a total of 17,603 units in 1 lot number was built on 23nov2020. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. A device history record review for model 22003e-07 lot number 20119619 was performed. The search showed that a total of 17,603 units in 1 lot number was built on 19nov2020. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. A device history record review for model 22003e-07 lot number 20119636 was performed. The search showed that a total of 17,603 units in 1 lot number was built on 20nov2020. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. A device history record review for model 22003e-07 lot number 20109559 was performed. The search showed that a total of 17,603 units in 1 lot number was built on 20oct2020. There was 1 quality notifications issued for the failure mode reported by the customer during the production build of this set. A device history record review for model 22003e-07 lot number 20109560 was performed. The search showed that a total of 17,603 units in 1 lot number was built on 21oct2021. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. Due to an increase in incidents of this failure mode, a trend for this occlusion issue has been identified for this product line. Capa# (b)(4) 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 multiple pressure rated ext set bonded ss 8. 5" were damaged and leaked. The following information was provided by the initial reporter: "patient ambulating around the unit and walked near the patc/ patc nurse called to say the "tubing broke"; pt had a bifuse connected and it came aprt at the end that connects to the patient. Patient returned with all of the components and a picture will be uploaded".
 
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Brand NamePRESSURE RATED EXT SET BONDED SS 8.5"
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
MDR Report Key12277418
MDR Text Key265176668
Report Number9616066-2021-51703
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/23/2021
Device Model Number22003E-07
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? Yes
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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