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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNSPECIFIED BD ANGIOCATH INTRAVASCULAR CATHETER

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UNSPECIFIED BD ANGIOCATH INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used as a default investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. Based on the available information we are not able to identify a root cause at this time. 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. Medical device expiration date: unknown. Device manufacture date: unknown. Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
 
Event Description
It was reported that an unspecified bd angiocath had a slow to retract needle. The following information was provided by the initial reporter: "one of our nurses brought a an angiocath to me that feels like it is grinding when pulling back on the needle retractor. ".
 
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Brand NameUNSPECIFIED BD ANGIOCATH
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12724253
MDR Text Key279650240
Report Number2243072-2021-02640
Device Sequence Number1
Product Code FOZ
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
Report Date 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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