MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25

Model Number N/A

Device Problems Detachment Of Device Component (1104); Fracture (1260); Leak/Splash (1354)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/22/2017

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebr0440 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility that the accucath was inserted after one attempt by staff rn with guidance from clinical specialist from bard.It was stated that five hours post insertion the catheter was leaking.When the dressing was removed it was found that the stat lock was intact but catheter had fractured at the hub and the cannula remained inside patient's vein.Catheter was removed with no harm to the patient reported.

Manufacturer Narrative

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 detached iv catheter is confirmed and was determined to be supplier related.One 20 g accucath iv was returned for evaluation.An initial visual observation showed the iv catheter was detached from the luer connector hub, and a large amount of blood residue was observed on both segments of the sample.A microscopic observation revealed the proximal end of the iv catheter was mostly straight and had radial striations on the majority of its surface.A section of the proximal end¿s surface was observed to be uneven, irregular, and plastically deformed.Plastic deformation was also observed in the catheter just distal to the proximal end; within this region, the surface of the catheter was observed to be more glossy and granular in texture.A slight kink was observed in the catheter approximately one centimeter distal to the proximal end of the catheter.Blood residue was observed in the luer connector hub; however no segment of the iv catheter could be seen within the luer connector hub.The sample was dissected in order to observe the inner lumen of the luer connector and strain relief.A ridge was observed just distal to the proximal opening of the strain relief.This ridge is evidence that the catheter was most-likely malposition during molding of the luer connector and strain relief.The sample was sent to the manufacturing facility for evaluation and it was confirmed that the cause of the catheter breakage it was due to bad positioning in the molding and failure in the stress test.The cause of this complaint is supplier related.The supplier was notified of this event; however, the component is no longer purchased from the supplier.The subject component was purchased from the supplier prior moving the manufacturing process for that component to a bard manufacturing facility.A lot history review (lhr) of rebr0440 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility that the accucath was inserted after one attempt by staff rn with guidance from clinical specialist from bard.It was stated that five hours post insertion the catheter was leaking.When the dressing was removed it was found that the stat lock was intact but catheter had fractured at the hub and the cannula remained inside patients vein.The patient required surgical intervention to remove the cannula, no other adverse outcome.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
• 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: 6644625
• MDR Text Key: 77702293
• Report Number: 3006260740-2017-00787
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948(17)180331(10)REBR0440
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: AC0202250
• Device Lot Number: REBR0440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/15/2017
• Supplement Dates Manufacturer Received: 06/29/2017
• Supplement Dates FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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