MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4F SL POWER MIDLINE CATHETER

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

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 leaking catheter was confirmed and the cause appeared to be use related.The product returned for evaluation was one 4fr s/l powermidline midline catheter.Usage residues were observed throughout the sample.A small split was observed approximately midway along the length of the extension tube.Microscopic inspection of the split revealed sharply defined fracture features.The fracture surface exhibited a granular fracture surface.Material abrasion was observed in the vicinity of the split, as well as circumferentially opposite the split site.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a leak was observed emanating from the site of the aforementioned split.The fracture features and material abrasions were consistent with damage caused by contact between the catheter and a traumatic grasping instrument such as forceps or hemostats.The product ifu states ¿caution: do not allow accidental device contact with sharp instruments.Mechanical damage may occur.Use only smooth edged, atraumatic clamps or forceps.¿ the location of the damage suggested that catheter maintenance may have contributed.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 line was intermittently leaking.Line was inserted 7/31 and got discontinued 7/3.We were unable to replace as the other arm was significantly swollen and piv was started after midline failure.No other information provided.

• Brand Name: 4F SL POWER MIDLINE CATHETER
• Type of Device: MIDLINE 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: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 8946665
• MDR Text Key: 156178125
• Report Number: 3006260740-2019-02528
• Device Sequence Number: 1
• Product Code: PND
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/07/2019
• 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