MAUDE Adverse Event Report: DOT PG PRO 18G 10CM FULL; 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 05/03/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reew4211 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "i was coaching a new vascular access rn through a powerglide pro insertion with use of a site-rite 8.Rn believed he was in the vessel, and advanced the guidewire.I asked if he felt resistance as he advanced the guidewire.He stated no, so i told him he could advance the catheter.The catheter advanced partly, but the rn was getting resistance.I told him to pull out, but he instead began to retract the catheter back over the needle.I told him to stop and pull the entire device out.After the device was retracted, i inspected it, and noticed a portion of the catheter was left in the patient." patient impact: "the catheter sheared when he retracted the catheter over the needle, and roughly an inch of the distal end of the catheter remained in the patient.The tourniquet was left on, and i notified the patient's rn.I asked her to contact the patient's primary doctor.An x-ray was ordered, and the remaining portion of the catheter was located in the tissue of the patient, and was not in the patient's vascular system.The primary rn told me it would just be a foreign body removal like a splinter.They were planning to make a small incision, and remove the catheter." additional information provided 05/04/2021: was there any patient harm reported? foreign body removal (tip of catheter) completed.

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 sheared powerglide pro catheter was confirmed.The product returned for evaluation was three photographs depicting an 18ga x 10cm powerglide pro midline catheter.A 20ga x 10cm powerglide pro was also depicted in each photograph and appeared to have been included as a reference.The first photograph depicted the advanced catheters and housings side by side.The 18ga catheter was observed to be fractured proximal of the tip.The second photograph depicted a closer view of the catheters.The distal end of the 18ga catheter appeared irregular.The third photograph depicted a closer view of the advanced guidewires.The 18ga guidewire exhibited curved shape memory.The guidewire deformation was consistent with advancement against resistance.The catheter damage was consistent with subsequent catheter withdrawal against the needle bevel.These observations appeared consistent with the event description.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 "i was coaching a new vascular access rn through a powerglide pro insertion with use of a site-rite 8.Rn believed he was in the vessel, and advanced the guidewire.I asked if he felt resistance as he advanced the guidewire.He stated no, so i told him he could advance the catheter.The catheter advanced partly, but the rn was getting resistance.I told him to pull out, but he instead began to retract the catheter back over the needle.I told him to stop and pull the entire device out.After the device was retracted, i inspected it, and noticed a portion of the catheter was left in the patient." patient impact: "the catheter sheared when he retracted the catheter over the needle, and roughly an inch of the distal end of the catheter remained in the patient.The tourniquet was left on, and i notified the patient's rn.I asked her to contact the patient's primary doctor.An x-ray was ordered, and the remaining portion of the catheter was located in the tissue of the patient, and was not in the patient's vascular system.The primary rn told me it would just be a foreign body removal like a splinter.They were planning to make a small incision, and remove the catheter." additional information provided 05/04/2021: ¿ was there any patient harm reported? foreign body removal (tip of catheter) completed.

• Brand Name: DOT PG PRO 18G 10CM FULL
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 11881616
• MDR Text Key: 257192767
• Report Number: 3006260740-2021-02017
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110566
• UDI-Public: (01)00801741110566
• Combination Product (y/n): N
• PMA/PMN Number: K153280
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• 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: F118101
• Device Lot Number: REEW4211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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
• Patient Age: 61 YR
• Patient Weight: 68