MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER 18GA X 10CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Difficult to Insert (1316); Defective Component (2292)

Patient Problem Discomfort (2330)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

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 it was difficult to advance cath through skin and vein.Successful after 3 attempts with same device.Complaint of discomfort.

Event Description

It was reported that it was difficult to advance cath through skin and vein.Successful after 3 attempts with same device.Complaint of discomfort.

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 difficult catheter insertion was confirmed and the cause was manufacturing-related.The product returned for evaluation was one 18ga x 10cm powerglide midline catheter.Usage residues were observed throughout the sample.The catheter tip appeared to be damaged.Microscopic inspection of the catheter tip confirmed it to be irregular.A small segment appeared to have broken off.The remainder of the catheter tip appeared to flare outward.A non-complainant needle was inserted into the catheter.The transition was rough between the catheter and the needle.The catheter tip damage appeared to be caused by insertion against resistance.It appeared that resistance was caused by a rough transition between the needle and catheter due to an improperly tipped catheter.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.----------------------------------------------------------------------------------------------------- reynosa evaluation complaint due to ¿difficult to advance catheter through skin and vein¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual and microscopical visual performed by vad field assurance the following was concluded: the catheter tip was found to be malformed.A rough transition between the needle shaft and the catheter results in the difficulty while attempting to insert through the patient¿s skin.This condition was caused during the catheter tipping process and it makes the device unusable for our customer.Therefore, the cause of this condition is manufacturing related.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: POWERGLIDE MIDLINE CATHETER 18GA X 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: 9957862
• MDR Text Key: 195240404
• Report Number: 3006260740-2020-01270
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Event Location: Hospital
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1