MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH GUARDIVA AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional 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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by customer that "powerglide tip catheter damage- tip broke off in patient.Device was "loose" out of package per rn." it was reported by the customer that "pt is super hard stick with dvt to rue and l subclavian completely occluded.Had piv in r ac that infiltrated.Attempted line in small vein 6cm distal to l ac.Vein immediately tied into a larger vein but wouldn't have had quite enough space if i stuck where it got larger so tried just below it.Vein was approx 1/2 cm deep so went in w almost a flat angle.Was a little off to one side so had to adjust angle sl.Looked like i was in vein and thought i had a little blood return in catheter so slid the guidewire off.Didn't seem to have any resistance.When i tried to slide off the catheter, it only went about 5cm and met resistance.I pulled it back onto needle without difficulty but was unable to disengage the guidewire to pull it back.The button wouldn't even push down.So, i slid the catheter back off as far as it would go and removed the housing without difficulty.Noted the guidewire had a bend to it.Was unable to aspirate any blood so slowly removed catheter while attempting to aspirate.Never got blood return and got to where i thought end of catheter was and it stuck! when i flushed it, it leaked out of insertion site and under the skin some.Tourniquet was still on to try to keep vein at max size.Could push the catheter back in about 1cm but again stuck when tried to pull it out.Tried just holding gentle traction on catheter and counter traction on skin, tried lightly massaging the tissue around insertion site.Rotated catheter slightly back and forth.On ultrasound it looked like catheter tip was just in vein but at 5 o'clock position.Cath lab nurse came to help.Tried the same things i tried.Eventually was able to remove it.Never applied force to it.When it came out we checked the tip and it looked sheared and then when compared to unused catheter and measured, there was 1.5 cm missing.Sent pt to er with tourniquet on.They did a doppler and didn't think there was a foreign body in the vein but said there appeared to be a thrombus near insertion site.Xray says there is 1.5cm foreign body in the soft tissue.And there was a thrombus to radial and cephalic veins and " vascular calcifications throughout the soft tissues".On xray his arm looks like it has ropes in it there is so much calcification and thrombus.The vein i was attempting was easily compressible.Er doc told him to follow up with his surgeon for possible removal." additional information 03/21/2023 patient did not receive an iv for long-term antibiotics.Unknown treatment or outcome following er.Patient was being treated for diabetic foot ulcer/long term iv antibiotics.Relevant history: pt has had numerous piccs bilaterally.Had known dvts in r arm.Had known total occlusion to left subclavian with only collateral blood flow.Pt's last piv was in r ac and infiltrated which resulted in need for iv access on this date.Venous doppler study of left arm in er (post attempted insertion) showed thrombus to radial and cephalic veins and " vascular calcifications throughout the soft tissues".Pt is near end of options for iv access.Has ejection fraction of 9% per wife.Surgeon reported pt not a candidate for port a cath placement.
Event or Problem Description
It was reported by customer that "powerglide tip catheter damage- tip broke off in patient.Device was "loose" out of package per rn." it was reported by the customer that "pt is super hard stick with dvt to rue and l subclavian completely occluded.Had piv in r ac that infiltrated.Attempted line in small vein 6cm distal to l ac.Vein immediately tied into a larger vein but wouldn't have had quite enough space if i stuck where it got larger so tried just below it.Vein was approx 1/2 cm deep so went in w almost a flat angle.Was a little off to one side so had to adjust angle sl.Looked like i was in vein and thought i had a little blood return in catheter so slid the guidewire off.Didn't seem to have any resistance.When i tried to slide off the catheter, it only went about 5cm and met resistance.I pulled it back onto needle without difficulty but was unable to disengage the guidewire to pull it back.The button wouldn't even push down.So, i slid the catheter back off as far as it would go and removed the housing without difficulty.Noted the guidewire had a bend to it.Was unable to aspirate any blood so slowly removed catheter while attempting to aspirate.Never got blood return and got to where i thought end of catheter was and it stuck! when i flushed it, it leaked out of insertion site and under the skin some.Tourniquet was still on to try to keep vein at max size.Could push the catheter back in about 1cm but again stuck when tried to pull it out.Tried just holding gentle traction on catheter and counter traction on skin, tried lightly massaging the tissue around insertion site.Rotated catheter slightly back and forth.On ultrasound it looked like catheter tip was just in vein but at 5 o'clock position.Cath lab nurse came to help.Tried the same things i tried.Eventually was able to remove it.Never applied force to it.When it came out we checked the tip and it looked sheared and then when compared to unused catheter and measured, there was 1.5 cm missing.Sent pt to er with tourniquet on.They did a doppler and didn't think there was a foreign body in the vein but said there appeared to be a thrombus near insertion site.Xray says there is 1.5cm foreign body in the soft tissue.And there was a thrombus to radial and cephalic veins and " vascular calcifications throughout the soft tissues".On xray his arm looks like it has ropes in it there is so much calcification and thrombus.The vein i was attempting was easily compressible.Er doc told him to follow up with his surgeon for possible removal." additional information 3/21/23 patient did not receive an iv for long-term antibiotics.Unknown treatment or outcome following er.Patient was being treated for diabetic foot ulcer/long term iv antibiotics.Relevant history: pt has had numerous piccs bilaterally.Had known dvts in r arm.Had known total occlusion to left subclavian with only collateral blood flow.Pt's last piv was in r ac and infiltrated which resulted in need for iv access on this date.Venous doppler study of left arm in er (post attempted insertion) showed thrombus to radial and cephalic veins and " vascular calcifications throughout the soft tissues".Pt is near end of options for iv access.Has ejection fraction of 9% per wife.Surgeon reported pt not a candidate for port a cath placement.
Additional 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 complaint of a catheter fracture is confirmed.One 20 ga x 10 cm powerglide pro was returned for evaluation.The guidewire and safety mechanism were returned in their advanced and activated positions.The catheter had been advanced off the needle and contained dried blood residues.The catheter tip appeared to be damaged and measured to be approximately 8.5 cm in length.Microscopic inspection of the damaged tip region revealed a v-shaped fracture.A longitudinal split was present proximal to the break location.The longitudinal split damage appeared to have been caused internally from the needle with the v-shaped fracture being the location of the puncture.The characteristic of the damage is consistent with damage caused by retraction of the catheter against the needle bevel.The product instructions for use (ifu) states, ¿warning: one the catheter has been advanced, do not reinsert the needle back into the catheter or pull on the catheter back onto the needle.If the needle needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter".

• Brand Name: FULL KIT 20G X 10 CM WITH GUARDIVA AND PROBE COVER
• Common Device Name: 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 Key: 16652987
• Report Number: 3006260740-2023-01076
• Device Sequence Number: 20458245
• Product Code: FOZ
• UDI-Device Identifier: 00801741140587
• UDI-Public: (01)00801741140587
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: F120108PT
• Device Lot Number: REGX0898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 81 KG