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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERGLIDE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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C.R. BARD, INC. (BASD) -3006260740 BARD POWERGLIDE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Detachment of Device or Device Component (2907); Activation Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2023
Event Type  malfunction  
Event Description
It was reported by the customer "the rn placed the line easily and when she retracted the device, only the wire and the bevel of the needle retracted.The needle was retained in the catheter.Both the catheter and the needle were successfully removed from the patient." no other information was provided.
 
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Manufacturer Narrative
The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached powerglide pro needle was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.Usage residues were visible on the sample.The catheter had been advanced and was not returned for evaluation.The safety mechanism was engaged over the needle tip.The needle shaft was completely detached from the plastic needle hub.Microscopic inspection of the needle shaft revealed a small amount of clear material near the proximal end.Inspection of the detached needle hub revealed it to appear well-formed.The needle detachment appeared to be caused by adhesive bond failure between the needle shaft and the needle hub.Adhesive may have been improperly applied or cured during device assembly.Photographs have been forwarded to the manufacturing site for further evaluation.
 
Event Description
It was reported by the customer "the rn placed the line easily and when she retracted the device, only the wire and the bevel of the needle retracted.The needle was retained in the catheter.Both the catheter and the needle were successfully removed from the patient." no other information was provided.
 
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Brand Name
BARD POWERGLIDE
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX   88780
Manufacturer Contact
suedabba mahboobi
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key16261211
MDR Text Key308841889
Report Number3006260740-2023-00254
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/25/2023
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
Patient Sequence Number1
Patient Outcome(s) Other;
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