MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number 6F120080

Device Problems Crack (1135); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reep4152 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when inserted to the patient it did not go in smoothly so the wire was checked with ultrasound and removed because the catheter tip was noted to be cracked.

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 powerglide pro catheter was confirmed.The product returned for evaluation was one 20ga x 8cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The sample was received fully assembled, with the catheter overlaying the needle shaft.The guidewire was fully retraced into the housing.The catheter terminated approximately 1cm proximal of the needle bevel.The distal end of the catheter appeared irregular.The distal fragment of the catheter was not returned for evaluation.Microscopic inspection of the catheter tip revealed a glossy and sharply defined fracture surface.The fracture exhibited a tapered profile.A longitudinally aligned scoring mark was observed on the inside surface of the catheter leading into the fracture.The fracture features were consistent with damage caused by retraction of the catheter against the needle tip.The blood residue suggested that occurred during attempted device placement.Such damage can occur if the catheter is withdrawn onto the needle and if the needle is reinserted following catheter advancement.The product ifu states ¿warning: once the catheter has been advanced, do not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.¿ h3 other text : evaluation findings are in section h.11.

Event Description

It was reported that when inserted to the patient it did not go in smoothly so the wire was checked with ultrasound and removed because the catheter tip was noted to be cracked.

• Brand Name: 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT
• 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
• MDR Report Key: 11380335
• MDR Text Key: 234920421
• Report Number: 3006260740-2021-00493
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 6F120080
• Device Lot Number: REEP4152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other