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
Medical Device Problem Codes	Material Frayed (1262); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that "accucath - retained guidewire in patient.Surgery was needed for removal." 12/5/22 additional information provided: vascular access team attempted to place an extended dwell intravenous line on the left upper extremity (accucath ace intravascular catheter 22g 1.25 inch) on (b)(6) 2022.The guidewire malfunctioned and was partially retained.The intravenous catheter and guidewire were not able to be removed from the patient's extremity.The break was noticed during insertion and confirmed with x-ray of left arm and ultrasound.Surgical team notified after removal.Surgery required to remove broken piece on (b)(6) 2022, operative note indicates a successful removal of the retained foreign body.Surgery was uncomplicated and no long-term patient effects.Patient is being treated for rsv.
Additional 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.Device not returned.
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 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 two 22ga x 1.25¿ accucath ace peripheral iv catheter assemblies.Usage residues were visible on both samples.Both samples were received with the safeties engaged.The needles were fully withdrawn into the housings.The catheters had been advanced and were not returned for evaluation.Inspection of the first sample (sample 1) revealed a break in the guidewire approximately 1cm distal of the needle tip.Microscopic inspection of the break in the guidewire revealed a granular fracture surface.A region of increased luster was observed on one edge of the fracture surface.Scoring marks were observed leading into the region of increased luster.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 buckled and flared outward and in the proximal direction.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.Gross, microscopic and functional evaluation of the second sample (sample 2) was unremarkable.The guidewire was undamaged.The sample appeared to have functioned as intended and may have been returned as a reference sample.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by the customer that "accucath - retained guidewire in patient.Surgery was needed for removal." 12/5/22 additional information provided: vascular access team attempted to place an extended dwell intravenous line on the left upper extremity (accucath ace intravascular catheter 22g 1.25 inch) on (b)(6) 2022.The guidewire malfunctioned and was partially retained.The intravenous catheter and guidewire were not able to be removed from the patient's extremity.The break was noticed during insertion and confirmed with x-ray of left arm and ultrasound.Surgical team notified after removal.Surgery required to remove broken piece on (b)(6) 2022, operative note indicates a successful removal of the retained foreign body.Surgery was uncomplicated and no long-term patient effects.Patient is being treated for rsv.(b)(6) 2022: clarification call with customer attempted placement was left upper extremity, mid forearm.Resistance was noted during retraction after the retraction button was pressed, no complications noted during insertion.Subsequent imagining noted that the catheter and guidewire were found within left forearm and were left in place.As noted during imaging, 'the radiopaque guidewire extended rom mind-forearm.Guidewire was likely in vessel, but catheter tip was not.Retrieved following day.' wire fragment has been removed from the patient.

• Brand Name: ACCUCATH ACE INTRAVASCULAR CATHETER 22GX1.25
• 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: 15988365
• Report Number: 3006260740-2022-05749
• Device Sequence Number: 14682605
• Product Code: FOZ
• UDI-Device Identifier: 00801741137938
• UDI-Public: (01)00801741137938
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K162894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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: 10/31/2023
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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: 6 MO
• Patient Sex: Female
• Patient Weight: 7 KG