MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH ACE INTRAVASCULAR CATHETER 22GX1.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/25/2022

Event Type  Injury  

Event Description

It was reported by the patient's mother "child was seen in children er in facility friday the 25th and ended up having to stay until monday the 28th because guide wires broke off into my 7 week olds vein.They decided not to take it out so now we are having to go to extra appointments for checkups and ultrasounds to make sure it doesn¿t move." add info rcvd 12/01/2022: it was reported by patient's mother: during placement of the iv using the intravascular catheter, the guidewire broke inside of her leg.Date of occurrence was (b)(6) ttef2022.The guy who placed it knew it broke when he pulled the guidewire out.She had multiple ultrasounds and one x-ray to locate this.No it has not been removed.I¿m not sure at what point in the insertion it broke.We don¿t know about long term harm.The doctors don¿t know what could happen other than ¿best case scenario is comes out of the skin.Otherwise we don¿t really know.We¿re going on uncharted waters¿.She will need many follow up ultrasounds and appointments to make sure it hasn¿t moved and to make sure her leg is okay after the tourniquet was on her for 5.5 hours.Additional information rcvd 12/05/2022: per patient's mother "she has a follow up with her pediatrician tomorrow.She went in for an ultrasound today to see if the guidewire has moved or not and i¿ll have the results tomorrow." add info rcvd 12/09/2022: the appointment went well, they did the ultrasound and the guidewire has not moved.She will have a follow up ultrasound in 2 weeks to make sure it doesn¿t move.The surgery team at facility is still uncomfortable removing it.(b)(6) 2022: clarification call with customer attempted placement location was the right popliteal.Wire fragment remains within the patient, within 'deep subcutaneous layer'.Placing clinician's note states that initial vessel access and insertion was uncomplicated.But further notes clarify that guidewire threaded slowly and without resistance.Upon subsequent catheter advancement some resistance was seen.A 'clicking' sound was heard after retraction button was pressed.Patient was receiving accucath due to fever, vomiting, and dehydration.There was a general lack of vessel availability.Ultrasound and x-ray confirmed the guidewire to be retained within the patient.Ultrasound findings indicated guidewire was adjacent to vein.X-ray found within deep subcutaneous layer.4.5mm from skin surface.Left a tourniquet in place while assessing situation.Surgical team didn¿t feel comfortable pulling.Ultimately patient was discharged.Current patient status is that they will watch the device, over time, and periodically re-assess needed action.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regt4148 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (regt4148) have been reported from the same facility.

Event Description

It was reported by the patient's mother "child was seen in children er in facility (b)(6) 2022 and ended up having to stay until (b)(6) 2022 because guide wires broke off into my 7 week olds vein.They decided not to take it out so now we are having to go to extra appointments for checkups and ultrasounds to make sure it doesn¿t move." add info rcvd 12/01/2022: it was reported by patient's mother: during placement of the iv using the intravascular catheter, the guidewire broke inside of her leg.Date of occurrence was (b)(6) 2022.The guy who placed it knew it broke when he pulled the guidewire out.She had multiple ultrasounds and one x-ray to locate this.No it has not been removed.I¿m not sure at what point in the insertion it broke.We don¿t know about long term harm.The doctors don¿t know what could happen other than ¿best case scenario is comes out of the skin.Otherwise we don¿t really know.We¿re going on uncharted waters¿.She will need many follow up ultrasounds and appointments to make sure it hasn¿t moved and to make sure her leg is okay after the tourniquet was on her for 5.5 hours.Additional information rcvd 12/05/2022: per patient's mother "she has a follow up with her pediatrician tomorrow.She went in for an ultrasound today to see if the guidewire has moved or not and i¿ll have the results tomorrow." add info rcvd 12/09/2022: the appointment went well, they did the ultrasound and the guidewire has not moved.She will have a follow up ultrasound in 2 weeks to make sure it doesn¿t move.The surgery team at facility is still uncomfortable removing it.(b)(6) 2022: clarification call with customer.Attempted placement location was the right popliteal.Wire fragment remains within the patient, within 'deep subcutaneous layer'.Placing clinician's note states that initial vessel access and insertion was uncomplicated.But further notes clarify that guidewire threaded slowly and without resistance.Upon subsequent catheter advancement some resistance was seen.A 'clicking' sound was heard after retraction button was pressed.Patient was receiving accucath due to fever, vomiting, and dehydration.There was a general lack of vessel availability.Ultrasound and x-ray confirmed the guidewire to be retained within the patient.Ultrasound findings indicated guidewire was adjacent to vein.X-ray found within deep subcutaneous layer.4.5mm from skin surface.Left a tourniquet in place while assessing situation.Surgical team didn¿t feel comfortable pulling.Ultimately patient was discharged.Current patient status is that they will watch the device, over time, and periodically re-assess needed action.

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 fractured guidewire was confirmed.The product returned for evaluation was one 22ga x 1.25¿ accucath ace peripheral iv catheter assembly.Usage residues were observed within the sample.The catheter had been advanced and was not returned for evaluation.The safety mechanism was activated and the needle was fully withdrawn into the housing.The guidewire appeared to be damaged within the coil region.Microscopic inspection of the guidewire confirmed deformation and a fracture within the coil region.The break surface exhibited a granular fracture surface.A region of increased luster was observed leading into the fracture site.Following disengagement of the safety mechanism, manipulation of the guidewire slider revealed the wire to be mobile within the needle shaft.Microscopic inspection of the needle revealed deformation along the proximal edge of the bevel.The bevel edge bulged outward.The needle tip appeared slightly blunted.The break features and needle deformation were consistent with damage caused by the guidewire being pulled against the proximal edge of the needle bevel.Such damage may occur if the guidewire tip becomes constrained, causing the wire to fold over the needle as the needle is inserted and if the wire is withdrawn against the needle at a sharp insertion angle.The product¿s instructions for use (ifu) warns against actions that can cause this to occur: "do not force or retract the guidewire.Retracting the guidewire may increase the risk of guidewire damage.If the guidewire must be retracted, remove the entire device to prevent the needle from damaging or shearing the guidewire.H3 other text : evaluation findings are in section h.11.

• Brand Name: ACCUCATH ACE INTRAVASCULAR CATHETER 22GX1.25
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16044720
• MDR Text Key: 306156235
• Report Number: 3006260740-2022-05867
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AC1221250
• Device Lot Number: REGT4148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 DA