MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (20G) (10CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Infiltration into Tissue (1931)

Event Date 05/29/2023

Event Type  malfunction  

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 manufacturer has received the sample and will evaluate.Results are expected soon.

Event Description

It was reported by the customer, "having issues with the powerglides at the tip near the pink to green hub having holes in them.Once we flush it, the site appears infiltrated but it's just because there's a hole in the catheter and so any meds sit in the subq tissue.It has happened at least 3 times." while pushing fluid through the catheter, there is a stream of fluid coming out of the side of the catheter, where a hole appears to be.This report addresses the first occurrence.

Event Description

It was reported by the customer, "having issues with the powerglides at the tip near the pink to green hub having holes in them.Once we flush it, the site appears infiltrated but it's just because there's a hole in the catheter and so any meds sit in the subq tissue." while pushing fluid through the catheter, there is a stream of fluid coming out of the side of the catheter, where a hole appears to be.Additional information received 06/12/2023: in two instances, they were flushed with a bit of the tip out and when flushed, it sprayed saline in the air.No harm occurred but we had to pull the line and start another.This report addresses the first spraying occurrence.

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 complaint of a catheter leak is confirmed but the exact cause remains unknown.One photo sample of a powerglide pro catheter implanted within a patient was provided for evaluation.An extension set is attached to the luer hub of the catheter.A stream of clear fluid is observed to be leaking from the proximal end of the catheter.The characteristics of the catheter leak location could not be closely inspected from the image.Based on the information provided, possible contributing factors include retraction of the catheter against the needle bevel after advancement.Since a leak in inserted catheter was observed, the complaint is confirmed; however, the exact cause could not be determined from the image provided.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported by the customer, "having issues with the powerglides at the tip near the pink to green hub having holes in them.Once we flush it, the site appears infiltrated but it's just because there's a hole in the catheter and so any meds sit in the subq tissue." while pushing fluid through the catheter, there is a stream of fluid coming out of the side of the catheter, where a hole appears to be.Additional information received 06/12/2023: in two instances, they were flushed with a bit of the tip out and when flushed, it sprayed saline in the air.No harm occurred but we had to pull the line and start another.This report addresses the first spraying occurrence.

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.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (20G) (10CM)
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17143612
• MDR Text Key: 317318098
• Report Number: 3006260740-2023-02477
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741142673
• UDI-Public: (01)00801741142673
• 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,Followup
• Report Date: 09/07/2023

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 Model Number: N/A
• Device Catalogue Number: F120100T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 06/12/2023; 09/07/2023
• Supplement Dates FDA Received: 06/23/2023; 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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