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

Model Number N/A

Device Problems Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/04/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refq1199 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.

Event Description

It was reported internal mechanism blocked, at the time the guidewire was inserted.The power slide was stuck in the vein and could not be moved.The client indicated that during the procedure something tangible broke on the internal mechanism.The surgeon had to remove the powerglide under local anesthesia.

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 damaged catheter was confirmed.One 22g x 8cm powerglide pro midline catheter was returned for investigation.The sample exhibited evidence of use.The catheter was received in two segments.The luer hub was present within the deployment system and attached to the wings.The catheter extended 1mm from the distal end of the blue strain relief sleeve on the luer hub.The remainder of the catheter was positioned over the distal tip of the needle.The proximal end of the distal catheter segment was crumpled and bunched over the needle tip.The break in the powerglide tubing appeared to be associated with sharp instrument damage that originated within the tubing.Other punctures were observed on the catheter shaft.The characteristics observed on the returned catheter are consistent with a needle puncture.It appears that the needle bevel was a contributing factor in the catheter break and punctures.The guidewire was intact.Due to the evidence of use observed on the returned sample, it appears that the user encountered complications during the insertion process.Warnings in the instructions for use (ifu) indicate that once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.This may result in damage to the catheter.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.The ifu also indicates to not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure.

Event Description

It was reported internal mechanism blocked, at the time the guidewire was inserted.The power slide was stuck in the vein and could not be moved.The client indicated that during the procedure something tangible broke on the internal mechanism.The surgeon had to remove the powerglide under local anesthesia.

• Brand Name: 22 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
• 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: 12705038
• MDR Text Key: 278589403
• Report Number: 3006260740-2021-04572
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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: 6F122080
• Device Lot Number: REFQ1199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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): Required Intervention