MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 22G X 8 CM 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 09/01/2022

Event Type  Injury  

Manufacturer Narrative

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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refs4817 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "received consult for midline placement and initially at bedside at 2200 on (b)(6) 2022 for placement.1st attempt to left upper arm would not advance in vein all the way.2nd attempt to left upper arm entered smoothly and was followed with ultrasound guidance until it was inserted up to the hub.Guidewire was then deployed and upon removal, became lodged ((b)(6) 2022 @2240).Heat initially applied and when it was evident that the catheter had sheared off, bedside rn and subsequently the md were immediately notified ((b)(6) 2022 @2250 & 2253).After multiple xrays were taken, the surgery team was ultimately contacted and first arrived at bedside @ 0023.At 0108 on (b)(6) 2022, md started procedure to remove the catheter and guidewire.At 0115 on (b)(6) 2022, guidewire and catheter were removed by surgeon and procedure was over at 0120.".

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 midline catheter damage/difficult device placement was confirmed.The product returned for evaluation was one 22ga x 8cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and was received loose.The safety cannister was detached and received loose.The needle terminated at the flash notch.The distal fragment, including the bevel was not returned for evaluation.The guidewire was intact but exhibited curved shape memory and permanent bends along the exposed region.The catheter terminated approximately 1cm distal of the molded joint.The distal catheter fragment was not returned for evaluation.Microscopic inspection of the guidewire revealed multiple misaligned coils near the weld tip.Microscopic inspection of the distal end of the introducer needle revealed a granular fracture surface.Material buckling was observed at the break site.Microscopic inspection of the distal end of the catheter revealed a tapered break profile.The break features were sharply defined and partially glossy and partially granular.A longitudinally aligned scoring mark was observed leading into the fracture site.The needle breakage was consistent with material failure due to sharp/repetitive bending of the needle at the flash notch.The catheter fracture features and longitudinal scoring mark were consistent with damage caused by contact between the catheter and the catheter shaft.Such damage may occur if the catheter is withdrawn or if the needle is reinserted following catheter advancement.The guidewire deformation was consistent with attempted advancement against resistance, such as into tissue.It appeared that resistance was likely initially encountered during attempted device placement.Subsequently, maneuvering of the catheter/needle appeared to cause catheter damage.Possibly during/following removal, shear stress placed on the needle likely resulted in needle fracture.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that attempt to left upper arm entered smoothly and was followed with ultrasound guidance until it was inserted up to the hub.Guidewire was then deployed and upon removal, became lodged ((b)(6) 2022 @2240).Heat initially applied and when it was evident that the catheter had sheared off, bedside rn and subsequently the md were immediately notified (9-1-2022 @2250 & 2253).After multiple xrays were taken, the surgery team was ultimately contacted and first arrived at bedside @ 0023.At 0108 on (b)(6) 2022, md started procedure to remove the catheter and guidewire.At 0115 on (b)(6) 2022, guidewire and catheter were removed by surgeon and procedure was over at 0120." (b)(6) 2022 - customer confirmed the insertion attempt was with a new device.

• Brand Name: BASIC KIT 22G X 8 CM 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15459005
• MDR Text Key: 300299953
• Report Number: 3006260740-2022-03660
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140549
• UDI-Public: (01)00801741140549
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: F322087T
• Device Lot Number: REFS4817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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