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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 22G X 8 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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C.R. BARD, INC. (BASD) -3006260740 FULL KIT 22G X 8 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Difficult to Remove (1528)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/18/2022
Event Type  Injury  
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refw1273 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported "was placing a midline to the right basilic vein, visualized catheter in vein, and then advanced the wire which went in easily.Next advanced the catheter and met some resistance at first but then went in smooth.Tried next to remove guidewire which came out halfway and stopped.Then tried to remove the whole catheter and wire and would not come out of skin.Called the adult crisis nurse to come to see if she could help remove.Tried to reinsert needle and that cut the catheter.Notified the apn who tried to use scalpel at site to see if that would free the catheter to come out but unable to hold the part of catheter under the skin, so next called the surgeon.Surgeon opened the skin about 3 cm and removed the catheter which appeared to have accordioned just under the skin.".
 
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refw1273 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported "was placing a midline to the right basilic vein, visualized catheter in vein, and then advanced the wire which went in easily.Next advanced the catheter and met some resistance at first but then went in smooth.Tried next to remove guidewire which came out halfway and stopped.Then tried to remove the whole catheter and wire and would not come out of skin.Called the adult crisis nurse to come to see if she could help remove.Tried to reinsert needle and that cut the catheter.Notified the apn who tried to use scalpel at site to see if that would free the catheter to come out but unable to hold the part of catheter under the skin, so next called the surgeon.Surgeon opened the skin about 3 cm and removed the catheter which appeared to have accordioned just under the skin.".
 
Event Description
It was reported "was placing a midline to the right basilic vein, visualized catheter in vein, and then advanced the wire which went in easily.Next advanced the catheter and met some resistance at first but then went in smooth.Tried next to remove guidewire which came out halfway and stopped.Then tried to remove the whole catheter and wire and would not come out of skin.Called the adult crisis nurse to come to see if she could help remove.Tried to reinsert needle and that cut the catheter.Notified the apn who tried to use scalpel at site to see if that would free the catheter to come out but unable to hold the part of catheter under the skin, so next called the surgeon.Surgeon opened the skin about 3 cm and removed the catheter which appeared to have accordioned just under the skin.".
 
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, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a difficult catheter insertion with deformation of the catheter material and difficulty removing the guidewire and catheter was confirmed but the cause is unknown.Two photographs of a damaged 8cm powerglide pro catheter were returned for evaluation.It appeared that the catheter had not deployed completely off of the needle and/or guidewire.The catheter appeared to have been cut or torn.As per the event description, an attempt was made to reinsert the needle which cause the catheter to become cut.The distal segment of the catheter was being grasped with a pair of hemostats.Directly distal of where the catheter was grasped, the material was bunched up upon itself in an accordion fashion.A high-resolution view of the catheter tip was not visible in the photo and therefore, it could not be determined if the catheter tip was damaged.The guidewire was also not visible in the photo and therefore it could not be determined if the guidewire was damaged.Reportedly, some resistance was felt while inserting the catheter.It is possible that the resistance during insertion contributed to the catheter damage and may have allowed the guidewire to become caught.It is unknown if the catheter became accordioned during the insertion procedure or while adjusting the device and trying to remove the guidewire and needle.The exact mechanism of damage could not be determined from the event description and returned photographs.Possible contributing factors could include the guidewire not being advanced fully into the vessel, excessive friction between the needle and catheter, a damaged catheter tip, or clinical technique.
 
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Brand Name
FULL KIT 22G X 8 CM WITH PROBE COVER
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
kayla olsen
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key13545928
MDR Text Key285733345
Report Number3006260740-2022-00352
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741140648
UDI-Public(01)00801741140648
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162377
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 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberF222088PT
Device Lot NumberREFW1273
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2021
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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