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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 6F120080
Device Problems Crack (1135); Defective Component (2292)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reeq2531 showed two other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(6).
 
Event Description
It was reported that when inserted to the patient it did not go in smoothly so the wire was checked with ultrasound and removed because the catheter tip was noted to be cracked.It was reported this occurred with three devices this report addresses the first device.
 
Event Description
It was reported that when inserted to the patient it did not go in smoothly so the wire was checked with ultrasound and removed because the catheter tip was noted to be cracked.It was reported this occurred with three devices this report addresses the first device.
 
Manufacturer Narrative
H11: section a through f - 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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged powerglide pro catheter was inconclusive because the implicated component of the device was not returned.The product returned for evaluation was one 20ga powerglide pro midline catheter placement assembly.Usage residues were observed throughout the sample.The guidewire was fully advanced and intact.The catheter had been advanced and the safety mechanism was in place over the needle tip.The implicated catheter was not returned for evaluation.Microscopic inspection of the sample was unremarkable.No deficiencies were discovered during evaluation of the returned sample; however, the implicated catheter was not returned with the placement assembly.Consequently this complaint is inconclusive at this time.
 
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Brand Name
20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT
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
MDR Report Key11380606
MDR Text Key239725508
Report Number3006260740-2021-00494
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6F120080
Device Lot NumberREEQ2531
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2021
Date Manufacturer Received05/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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