MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. -9617592 ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number AC0202250

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

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, 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 damaged catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 2.25¿ accucath catheter.Blood residue was evident within the catheter tube.The sample was received in two segments which shared a complete break approximately 2cm distal of the molded joint.Multiple kinks were apparent along the length of the distal fragment.The break appeared irregular.Elongation and curved shape memory were evident in the vicinity of the break.Microscopic inspection of the break confirmed extensive deformation/elongation.The break surface was partially granular and partially striated.The striated region exhibited a tapered profile.Inspection of the tip of the catheter revealed deformation.The catheter fracture features were consistent with damage that was initiated by contact between the catheter and the needle tip and propagated by tensile (pulling) stress.The abundant kinks and catheter tip damage suggested possible difficulty experienced during catheter insertion/guidewire retraction.The product ifu states ¿warning: do not force or retract the guidewire.¿ and ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ a lot history review (lhr) of recn0849 showed no other similar product complaint(s) from this lot number.(b)(4).

Event Description

It was reported that patient was undergoing an insertion of a peripheral vascular access device using ultrasound.Accucath was inserted and wire advanced without difficulty in right cephalic vein with good blood return noted.During retraction of wire the wire got "hung up" and the practitioner attempted to pull back on the catheter.The needle tip caught the end of the catheter resulting in a shearing off of the tip of the catheter.The iv catheter tip was surgically removed and patient tolerated procedure without complications noted.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7651921
• MDR Text Key: 112788581
• Report Number: 3006260740-2018-01563
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2018,06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AC0202250
• Device Catalogue Number: AC0202250
• Device Lot Number: RECN0849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2018
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• 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
• Patient Outcome(s): Required Intervention