MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 20G X 8CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/25/2022

Event Type  Injury  

Event Description

It was reported "powerglide catheter removed by customer and 5.5cm of the catheter broke off at a kinked sight into the patient.Patient currently has 5.5cm of catheter inside of them.They are ordering a doppler to find out where the catheter is.If the piece is not in the vein and in the soft tissue, they will leave it." additional information received 04/01/2022 patient was admitted for etoh intoxication.Patient was a known difficult iv stick who required us guided ivs or midline during multiple past admissions."i was attempting to a place this midline in right brachial vein in upper arm using ultrasound.The tip of needle was visualized with flash back and guidewire was deployed.The catheter was then advanced.I, however, could not flush or aspirate blood.I began to withdraw the catheter as i presumed that it had kinked.As i was doing so the catheter broke at 2.5cm.There remained 5.5cm of it in right arm.My immediate us images did not show the catheter inside the lumen of brachial vein but did show the retained catheter in the soft tissue.Patient¿s team resident and interventional radiologist were immediately informed.There was no bleeding, swelling, or complaints of pain from patient following the incident.Xr of right humerus confirmed retained product.Doppler us of right upper arm indicated retained catheter within the lumen of mid right brachial vein.Vascular surgery was consulted.Cutdow0 n was performed by vascular surgery and the retained catheter was removed on (b)(6 2022 pt was discharged (b)(6) 2022 and to follow up in 2-3 weeks for staples removal and wound check.".

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refy3833 showed no other similar product complaint(s) from this lot number.

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 catheter was confirmed.The product returned for evaluation was one 20ga x 8cm powerglide pro midline catheter.The catheter had been advanced and the placement assembly was not returned.Usage residues were observed throughout the catheter.The catheter terminated 2.6cm from the molded joint.The distal catheter fragment was not returned for evaluation.The fracture appeared irregular and exhibited a tapered profile.Microscopic inspection of the fracture surface revealed a partially granular and partially glossy surface.A longitudinally aligned scoring mark was observed on the inside surface of the catheter shaft leading into the fracture.The fracture features were consistent with damage initiated by contact between the catheter shaft and introducer needle tip.Such damage can occur if the catheter is withdrawn or if the needle is re-inserted following catheter advancement.H3 other text: evaluation findings are in section h11.

Event Description

It was reported "powerglide catheter removed by customer and 5.5cm of the catheter broke off at a kinked sight into the patient.Patient currently has 5.5cm of catheter inside of them.They are ordering a doppler to find out where the catheter is.If the piece is not in the vein and in the soft tissue, they will leave it." additional information received 04/01/2022 patient was admitted for etoh intoxication.Patient was a known difficult iv stick who required us guided ivs or midline during multiple past admissions."i was attempting to a place this midline in right brachial vein in upper arm using ultrasound.The tip of needle was visualized with flash back and guidewire was deployed.The catheter was then advanced.I, however, could not flush or aspirate blood.I began to withdraw the catheter as i presumed that it had kinked.As i was doing so the catheter broke at 2.5cm.There remained 5.5cm of it in right arm.My immediate us images did not show the catheter inside the lumen of brachial vein but did show the retained catheter in the soft tissue.Patient¿s team resident and interventional radiologist were immediately informed.There was no bleeding, swelling, or complaints of pain from patient following the incident.Xr of right humerus confirmed retained product.Doppler us of right upper arm indicated retained catheter within the lumen of mid right brachial vein.Vascular surgery was consulted.Cutdown was performed by vascular surgery and the retained catheter was removed on (b)(6) 2022 pt was discharged (b)(6) 2022 and to follow up in 2-3 weeks for staples removal and wound check.".

• Brand Name: BASIC KIT 20G X 8CM WITH BIOPATCH
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14117557
• MDR Text Key: 289331259
• Report Number: 3006260740-2022-01291
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140525
• UDI-Public: (01)00801741140525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• 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: 06/01/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F320087T
• Device Lot Number: REFY3833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 06/01/2022
• Supplement Dates FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male