MAUDE Adverse Event Report: FULL KIT 20G X 10 CM WITH BIOPATCH AND PROBE COVER; 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 06/23/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refq4667 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "issue with powerglide midline where piece of catheter broke off inside patient during insertion, ir had to remove piece of catheter from patient.".

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 broken powerglide was confirmed.The product returned for evaluation was one 20ga x 10cm powerglide pro midline catheter assembly.The sample was received fully disassembled.Usage residues were observed throughout the sample.The catheter was received in two segments which shared a complete break 4.5cm from the molded joint.Microscopic inspection of the break revealed a partially granular and partially glossy fracture surface.The break profile was tapered.A longitudinally aligned scoring mark was observed on the inside surface of the catheter leading into the break site.The break features were consistent with catheter damage caused either by withdrawal of the catheter or insertion of the needle following catheter advancement.The blood residues present on the device suggested that damage occurred during attempted device placement.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 Description

It was reported "issue with powerglide midline where piece of catheter broke off inside patient during insertion, ir had to remove piece of catheter from patient.".

• Brand Name: FULL KIT 20G X 10 CM WITH BIOPATCH AND PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12181711
• MDR Text Key: 261969084
• Report Number: 3006260740-2021-02776
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140686
• UDI-Public: (01)00801741140686
• 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,other
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• 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: F320108PT
• Device Lot Number: REFQ4667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Date Manufacturer Received: 08/06/2021
• 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