MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (22G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F122080T
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reeu1755 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "midline attempt by me rn iv team with ultrasound-guided bard powerglidepro midline catheter 22g, 8cm lot# reeu1755 in pt's right cephalic vein.After vein cannulated as evidenced by flash and u/s, and guidewire threaded, i attempted to pull entire device including needle/guidewire from the catheter, but met resistance.Not wanting to cause damage to the vein, rn iv team consulted.Upon assessment, manufacturer malfunction/catheter separation from needle suspected.Tourniquet applied to right upper arm considering possible risk of catheter floating/causing emboli.Primary rn paged primary, trauma team, and dr.Reported to bedside.Md assessed situation and was able to pull dislodged catheter and entire midline device from pt's arm with tweezers at 14:40.Pressure held at site, hemostasis achieved; petroleum gauze, 4x4, and transparent dressing applied to site.Site soft upon palpation, no s/s hematoma.All components of powerglide including packaging kept and will be turned over to risk management" additional information received (b)(6) 2021: what theyre being treated for: sdh/sah with midline shift.
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 difficult insertion/catheter damage 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 the safety mechanism was engaged over the needle tip.The catheter exhibited a complete break just distal of the molded joint.The catheter was crumpled in the vicinity of the break and exhibited deformation along most of its length.Microscopic inspection of the break revealed a tapered break profile.The fracture surface was glossy and sharply defined.A longitudinally aligned scoring mark was observed on the inside surface of the catheter leading into the break site.Inspection of the distal end of the catheter revealed buckling.The catheter deformation and fracture were consistent with damage caused by initial attempted advancement against resistance, such as into tissue, followed by withdrawal against the needle tip.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.¿.
Event or Problem Description
It was reported "midline attempt by me rn iv team with ultrasound-guided bard powerglidepro midline catheter 22g, 8cm lot# reeu1755 in pt's right cephalic vein.After vein cannulated as evidenced by flash and u/s, and guidewire threaded, i attempted to pull entire device including needle/guidewire from the catheter, but met resistance.Not wanting to cause damage to the vein, rn iv team consulted.Upon assessment, manufacturer malfunction/catheter separation from needle suspected.Tourniquet applied to right upper arm considering possible risk of catheter floating/causing emboli.Primary rn paged primary, trauma team, and dr.Reported to bedside.Md assessed situation and was able to pull dislodged catheter and entire midline device from pt's arm with tweezers at 14:40.Pressure held at site, hemostasis achieved; petroleum gauze, 4x4, and transparent dressing applied to site.Site soft upon palpation, no s/s hematoma.All components of powerglide including packaging kept and will be turned over to risk management".

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (22G) (8CM)
• 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
• MDR Report Key: 11474636
• Report Number: 3006260740-2021-00804
• Device Sequence Number: 3413381
• Product Code: FOZ
• UDI-Device Identifier: 00801741142680
• UDI-Public: (01)00801741142680
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: F122080T
• Device Catalogue Number: F122080T
• Device Lot Number: REEU1755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/22/2021
• 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: Other
• Patient Age: 81 YR
• Patient Weight: 152