MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 20G 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY

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	08/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redw0537 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "a 1cm section of the catheter sheered off during insertion." "on (b)(6) 2020, i attempted a very difficult placement of a 20g 8cm powerglide pro (lot # redw0537) into a tortuous right cephalic vein.The vessel started at about 0.5cm deep.I inserted the needle approximately 2cm, threaded the guidewire, followed by the catheter.The catheter would not advance more than approximately 4cm.I pulled back the device including catheter, guidewire, and needle and met resistance.The housing and guidewire continued out easily, leaving the catheter behind with a visible shear close to the end of the catheter.I attempted to grab the distal portion of the catheter with sterile hemostats and gently remove.The distal and proximal portions of the catheter separated with minimal effort.The removed catheter measured 7cm with a jagged edge.This incident occurred in the micu, and i called the critical care md to the bedside, who assessed with ultrasound and found what he suspected to be artifact caused by the catheter in the subcutaneous tissue proximal to my insertion site.A stat ct of the right upper extremity w/ iv contrast and chest ct angiogram pulmonary emboli protocol w/iv contrast were ordered and completed approximately 4 hours after the order was placed.The ct scan showed a 1 cm foreign body in the subcutaneous tissue of the right upper extremity." "i do not believe this incident was caused by product failure.I think that during the removal process i withdrew the catheter over the needle, puncturing it.Immediately after the md assessed the patient, another powerglide pro was placed in the left upper extremity by another vascular access nurse also with great difficulty due to her edema and difficult vasculature.An incident report was filed, and the entire powerglide device housing, catheter, and packaging were provided to my clinician.I spoke with the critical care md this evening, and to my knowledge no treatment is necessary or planned for the 1cm subcutaneous catheter remnant.".
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 sheared catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 8cm powerglide pro midline catheter.Use residues were observed throughout the sample.The catheter terminated 7.1cm from the molded joint.The distal tip was irregular.The distal catheter fragment was not returned for evaluation.Microscopic inspection of the distal end of the sample revealed a tapered fracture profile.The break surface exhibited a primarily granular fracture surface with a glossy region.A longitudinally aligned scoring mark was observed on the inside surface of the catheter leading into the break site.The fracture features and scoring mark were consistent with catheter damage caused by contact with the introducer needle tip.It appeared that following catheter insertion or partial insertion, either the catheter was retracted against the needle tip or the needle was re-inserted into the catheter.The product ifu states ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter 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.¿ a lot history review (lhr) of redw0537 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "a 1cm section of the catheter sheered off during insertion." "on (b)(6) 2020, i attempted a very difficult placement of a 20g 8cm powerglide pro (lot # redw0537) into a tortuous right cephalic vein.The vessel started at about 0.5cm deep.I inserted the needle approximately 2cm, threaded the guidewire, followed by the catheter.The catheter would not advance more than approximately 4cm.I pulled back the device including catheter, guidewire, and needle and met resistance.The housing and guidewire continued out easily, leaving the catheter behind with a visible shear close to the end of the catheter.I attempted to grab the distal portion of the catheter with sterile hemostats and gently remove.The distal and proximal portions of the catheter separated with minimal effort.The removed catheter measured 7cm with a jagged edge.This incident occurred in the micu, and i called the critical care md to the bedside, who assessed with ultrasound and found what he suspected to be artifact caused by the catheter in the subcutaneous tissue proximal to my insertion site.A stat ct of the right upper extremity w/ iv contrast and chest ct angiogram pulmonary emboli protocol w/iv contrast were ordered and completed approximately 4 hours after the order was placed.The ct scan showed a 1 cm foreign body in the subcutaneous tissue of the right upper extremity." "i do not believe this incident was caused by product failure.I think that during the removal process i withdrew the catheter over the needle, puncturing it.Immediately after the md assessed the patient, another powerglide pro was placed in the left upper extremity by another vascular access nurse also with great difficulty due to her edema and difficult vasculature.An incident report was filed, and the entire powerglide device housing, catheter, and packaging were provided to my clinician.I spoke with the critical care md this evening, and to my knowledge no treatment is necessary or planned for the 1cm subcutaneous catheter remnant.".

• Brand Name: PG PRO 20G 8CM BASIC KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10518006
• Report Number: 3006260740-2020-03205
• Device Sequence Number: 14091861
• Product Code: FOZ
• UDI-Device Identifier: 00801741110528
• UDI-Public: (01)00801741110528
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: F120080
• Device Lot Number: REDW0537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 67 YR
• Patient Weight: 88