MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER; INTRAVASCULAR CATHETER LESS THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Phlebitis (2004); Swelling (2091)

Event Date 02/03/2017

Event Type  Injury  

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 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 complete break in the catheter was confirmed, but the exact mechanism of damage is unknown.The distal segment of a powerglide type catheter was returned for investigation.The catheter segment was found to be 1.35 cm in length.A microscopic examination of the distal tip of the catheter revealed residue within the opening of the catheter, which was out of round.What appeared to be fibrin formation was observed within the proximal opening of the catheter.The fibrin material was pulled away from the proximal opening of the catheter segment, which revealed an uneven surface.The catheter came to a point at the proximal end and showed a scalloped edge from the inner wall to the outer wall.Uneven and sharp edges were observed in the proximal end of the tubing.Portions of the cross sectional surface exhibited greater luster than other areas of the cross section.The break or segmentation of the catheter could be a result of complications with the insertion process.A breach in the catheter may have been initiated with the sharp edge of the needle tip.The product ifu states, ¿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 states, ¿do not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure.¿ no further action is required because 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) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

Facility reported to the sales representative that the catheter was placed in the right cephalic vein, patient presented with thrombophlebitis.It was stated that the catheter was disconnected with no notes on any issues or complications recognized at time of removal.The patient was later admitted for several concerns; one being the arm was swollen.An ultrasound was done on the patient's arm and visualized catheter fragment.The patient had to have the piece removed via ultrasound and fluoroscopic guided intravascular foreign body removal with sedation.Iv antibiotics administered, no further treatment required.New device was placed.

• Brand Name: POWERGLIDE MIDLINE CATHETER
• Type of Device: INTRAVASCULAR CATHETER LESS THAN 30 DAYS
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6425144
• MDR Text Key: 70625310
• Report Number: 3006260740-2017-00283
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 03/22/2017
• 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): Required Intervention
• Patient Age: 63 YR