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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCUCATH, ACE 20GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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ACCUCATH, ACE 20GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/26/2021
Event Type  malfunction  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents. Based on a review of this information, the following was concluded: the complaint of a bent needle is confirmed; however, the exact cause is unknown. One 20 g x 2. 25 in. Accucath ace was returned for evaluation. An initial visual observation showed no obvious evidence of use on the returned sample. The needle of the device was observed to be bent at its base within the housing. The safety mechanism of the device appeared to have been activated but it was unable to retract the needle due to the angle of the bend. Based on the evidence provided with the returned sample, it is unknown when or how the bend occurred in the needle. Damage to the needle could have occurred at the manufacturing facility, during shipping, during use, or during storage of the product, and no evidence was observed which supported a specific root cause of the event. A lot history review (lhr) of rees1500 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported "a brand new, unused 20g catheter was opened to find the catheter bent at a 45 degree angle. " on (b)(6) 2021, the returned sample exhibited a bent needle. The safety mechanism of the device appeared to have been activated but it was unable to retract the needle due to the angle of the bend.
 
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Brand NameACCUCATH, ACE 20GX2.25
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12550881
MDR Text Key274019591
Report Number3006260740-2021-04048
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K162894
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberAC1202250
Device Lot NumberREES1500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2020
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: 09/29/2021 Patient Sequence Number: 1
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