MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER 20G, 8CM W/ BASIC TRAY INTRAVASCULAR CATHETER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the complaint of a powerglide catheter dislodging from its hub is confirmed, but the cause of the event cannot be determined. Visual observation of the labeling confirmed the reported lot and catalog numbers. Evaluation of the photograph of the device found that no catheter tubing could be seen in or extending from the powerglide catheter hub. The purple hub and pink strain relief were both present, and no damage to either was obvious. The device appeared to be used. While the complaint was confirmed, the sample received and information available do not allow for a determination of root cause. The complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use. A lot history review (lhr) of rebr0522 showed no other similar product complaint(s) from this lot number. The following ifu statements may be useful: ¿to avert device damage and/or patient injury during placement: do not allow accidental device contact with sharp instruments. Mechanical damage may occur. Use only smooth edged, atraumatic clamps or forceps. ¿ ¿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. 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 describes statlock attachment procedure, includes the following: ¿8. Minimize catheter/tube manipulation during application and removal of the statlock® stabilization device. ¿.

Event Description

Facility reported to the sales rep that they had a powerglide catheter dislodge from the hub during insertion. The catheter was placed in the patient's forearm/cephalic. A tourniquet was placed above the site to reduce the chance of the catheter migrating. Patient going to surgery for removal. No injury to patient was reported.

Manufacturer Narrative

The information provided by bard 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 bard. The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of rebr0522 showed no other similar product complaint(s) from this lot number.

Event Description

Facility reported to the sales rep that they had a powerglide catheter dislodge from the hub during insertion. The catheter was placed in the patient's forearm/cephalic. A tourniquet was placed above the site to reduce the chance of the catheter migrating. Patient going to surgery for removal.

• Brand Name: POWERGLIDE MIDLINE CATHETER 20G, 8CM W/ BASIC TRAY
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6975994
• MDR Text Key: 192869718
• Report Number: 3006260740-2017-01900
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: M120080
• Device Lot Number: REBR0522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial