MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Date 11/06/2017

Event Type  malfunction  

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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the powerglide pro was placed on the (b)(6) 2017.On (b)(6) 2017 the ward called the anesthesiology department who placed the powerglide pro about problems with the catheter.It was stated that when attempting to flush the catheter, saline leaked out from a hole near the hub.The powerglide pro was removed.There was no reported harm to the patient.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend 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 leaking catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 10cm powerglide pro catheter.The assembly was not returned.The catheter exhibited curved shape memory.The tip appeared discolored.Diagonally aligned split was observed in the catheter just distal of the molded joint.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a spraying leak was observed emanating from the site of the aforementioned split.Microscopic inspection of the split revealed sharply defined fracture features.The fracture exhibited a tapered profile.Discoloration and surface abrasions were observed in the vicinity of the split.The split shape and accompanying surface abrasion was consistent with damage caused by sample manipulation with a traumatic instrument such as forceps or hemostats.The product ifu states ¿do not allow accidental device contact with sharp instruments.Mechanical damage may occur.Use only smooth edged, atraumatic clamps or forceps.¿ a lot history review (lhr) of rebs2825 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported that the powerglide pro was placed on the (b)(6) 2017.On the (b)(6) 2017 the ward called the anesthesiology department who placed the powerglide pro about problems with the catheter.It was stated that when attempting to flush the catheter, saline leaked out from a hole near the hub.The powerglide pro was removed.There was no reported harm to the patient.

• Brand Name: 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM 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: 7115323
• MDR Text Key: 95065770
• Report Number: 3006260740-2017-02223
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6F120100
• Device Lot Number: REBS2825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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