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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (18G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (18G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/13/2022
Event Type  Injury  
Event Description
It was reported via medwatch "during a midline catheter placement, the vein was accessed, however, the catheter was unable to be successfully threaded over the device's guide wire.The procedure was stopped and the device was withdrawn.Upon removal and inspection of the midline device, the guidewire was not present or attached to the device.X-ray obtained and revealed the presence of foreign body to the left lower calf.Patient was taken to the operating room for foreign body removal." additional information received 09/27/2022: were all the missing pieces retrieved and accounted for? yes.
 
Manufacturer Narrative
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regq1489 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported via medwatch "during a midline catheter placement, the vein was accessed, however, the catheter was unable to be successfully threaded over the device's guide wire.The procedure was stopped and the device was withdrawn.Upon removal and inspection of the midline device, the guidewire was not present or attached to the device.X-ray obtained and revealed the presence of foreign body to the left lower calf.Patient was taken to the operating room for foreign body removal." additional information received 09/27/2022: were all the missing pieces retrieved and accounted for? yes.
 
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 midline catheter was confirmed.The product returned for evaluation was one 18ga powerglide pro rt midline catheter.The returned sample comprised a segment of catheter shaft approximately 2cm long.The fragment included the distal tip.The proximal catheter segment, including the luer adapter was not returned.Usage residues were observed throughout the sample.The break exhibited a tapered profile.Microscopic inspection of the break confirmed a tapered profile.The break surface was partially granular and partially glossy.Microscopic inspection of the catheter revealed folding and buckling of the distal tip.Material discoloration was observed in the vicinity of the deformation.The catheter break features were consistent with damage initiated by contact between the catheter shaft and the needle tip.Such damage can occur if the catheter is withdrawn or if the needle is reinserted following catheter advancement.The catheter tip deformation suggested that insertion against resistance, such as into tissue, likely contributed.
 
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Brand Name
POWERGLIDE PRO MIDLINE CATHETER (18G) (8CM)
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
becky garcia
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key15505333
MDR Text Key300807041
Report Number3006260740-2022-03811
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741142642
UDI-Public(01)00801741142642
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberF118080T
Device Lot NumberREGQ1489
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2022
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) Required Intervention;
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