MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT; 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 04/29/2022

Event Type  Injury  

Event Description

It was reported experienced inserter attempted insertion of powerglide pro on a difficult iv access (diva) patient.Patient is a iv drug abuser with poor venous access.Inserted was difficult.It was shared that the guidewire was difficult to advance as was the cannula follow that.The inserter managed to advance the cannula in the end of the insertion.(reporter did not vocalize if there was any ultrasound confirmation that the line was in the vein.) when the line was removed slightly later because it was not working.It was observed to be shorter than expected.Upon further inspection it was realized that part of the catheter tip was dethatched from the main catheter the reminder of the line was found to be in the patient's arm and was later removed with forceps.Patient was well after incident.Another powerglide pro was inserted on the opposite upper arm and power injection was completed without incident.This line was removed without incident.

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

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.

Event Description

It was reported experienced inserter attempted insertion of powerglide pro on a difficult iv access (diva) patient.Patient is a iv drug abuser with poor venous access.Inserted was difficult.It was shared that the guidewire was difficult to advance as was the cannula follow that.The inserter managed to advance the cannula in the end of the insertion.(reporter did not vocalize if there was any ultrasound confirmation that the line was in the vein.) when the line was removed slightly later because it was not working.It was observed to be shorter than expected.Upon further inspection it was realized that part of the catheter tip was dethatched from the main catheter the reminder of the line was found to be in the patient's arm and was later removed with forceps.Patient was well after incident.Another powerglide pro was inserted on the opposite upper arm and power injection was completed without incident.This line was removed without incident.Additional information: it was informed to me that they had visualized the catheter in the vein via ultrasound.However was not able to deploy powerglide pro catheter successfully.Further probing of the matter, it was shared that there was manipulation of the catheter before it was removed from the patient.It was at this point that the damage to the catheter was discovered.

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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.¿ based on a review of this information, the following was concluded: the complaint of a catheter break is confirmed.One powerglide pro open package indicates lot: refx4463, one powerglide pro device housing with safety activated, and two 10 cm powerglide catheters were returned for evaluation.One of the catheters was returned with a complete break in the catheter which measured to be 2.5 cm in length.The event description does not allege any issues on the additional catheter sample returned.Blood residue was visible on the returned samples.Microscopic observation of the break surface revealed it to be slanted with peak in the catheter material.The proximal end of the break surface contained a partial longitudinal split corresponding to the peak of the catheter surface.The angle of the split and location of the damage is consistent with damage caused by the needle.This damage may occur if the needle is re-inserted after the catheter has been advanced.The product instructions for use (ifu) warns, ¿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.¿ since a complete break in the catheter was found, the complaint is confirmed.A lot history review (lhr) of refx4463 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported experienced inserter attempted insertion of powerglide pro on a difficult iv access (diva) patient.Patient is a iv drug abuser with poor venous access.Inserted was difficult.It was shared that the guidewire was difficult to advance as was the cannula follow that.The inserter managed to advance the cannula in the end of the insertion.(reporter did not vocalize if there was any ultrasound confirmation that the line was in the vein.) when the line was removed slightly later because it was not working.It was observed to be shorter than expected.Upon further inspection it was realized that part of the catheter tip was dethatched from the main catheter the reminder of the line was found to be in the patient's arm and was later removed with forceps.Patient was well after incident.Another powerglide pro was inserted on the opposite upper arm and power injection was completed without incident.This line was removed without incident.

• Brand Name: 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14458925
• MDR Text Key: 292193330
• Report Number: 3006260740-2022-01848
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

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: 6F120100
• Device Lot Number: REFX4463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 07/08/2022; 08/02/2022
• Supplement Dates FDA Received: 07/18/2022; 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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): Other