MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25

Model Number N/A

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem Blood Loss (2597)

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 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 leak was confirmed, but the exact cause is unknown.One 20g x 1.25¿ accucath catheter was returned for investigation.The catheter was received without the handle.A functional test revealed a leak approximately 6mm distal to the purple strain relief sleeve.A 0.0017¿ hole pointing in the distal direction from inside the catheter to the external surface of the tubing was observed at the leak site.The size of the hole is larger than the outside diameter (od) of the guidewire and smaller than the od of the needle.It is possible that the catheter was punctured with the needle tip, but the exact mechanism of damage is unknown.The product ifu warns, ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.¿ a lot history review (lhr) of reaw1058 showed no other similar product complaint(s) from this lot number.

Event Description

As reported by nurse at the facility, they noticed that there was a hole in the proximal third of the catheter where blood was dripping out before fully threading the catheter in the vein.When he noticed the leaking, he removed the catheter from the patient and placed another iv.The patient was not harmed.

• Brand Name: ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25
• Type of Device: INTRAVASCULAR 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6584610
• MDR Text Key: 75927178
• Report Number: 3006260740-2017-00668
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110917
• UDI-Public: (01)00801741110917(17)171228(10)REAW1058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153298
• 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: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: N/A
• Device Catalogue Number: AC0201250
• Device Lot Number: REAW1058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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