MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE ST MIDLINE CATHETER FULL KIT (18G) (10CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redq4005 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the midline was placed (b)(6) 2019, was found to be leaking on (b)(6) 2019.The line was replaced on (b)(6) 2019.Patient was not harmed.

Event Description

It was reported that the midline was placed(b)(6)2019 , was found to be leaking on 10/24/19.The line was replaced on 10/25/19.Patient was not harmed.

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 leaking catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 10cm powerglide pro st midline catheter.Usage residues were observed throughout the sample and an extension set was attached to the luer adapter.A partially circumferential split was observed just distal of the molded joint.The split occurred in the vicinity of a permanent kink impression.Microscopic inspection of the split revealed granular fracture edges.Material buckling, deformation and discoloration were observed in the vicinity of the split.The split characteristics were consistent with sharp and repetitive kinking of the catheter shaft, leading to material failure.The location of the damage suggested that catheter securement, access and maintenance techniques may have contributed.A lot history review (lhr) of redq4005 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERGLIDE ST MIDLINE CATHETER FULL KIT (18G) (10CM)
• 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
• MDR Report Key: 9624859
• MDR Text Key: 193311691
• Report Number: 3006260740-2020-00275
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741139291
• UDI-Public: (01)00801741139291
• Combination Product (y/n): N
• PMA/PMN Number: K170158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• 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: ST118101
• Device Lot Number: REDQ4005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Event Location: Hospital
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1